Home / Leading CDMO Companies in Japan

Leading CDMO Companies in Japan

Your Trusted Japanese Partners for Pharmaceutical Development and Contract Manufacturing

  
Aenova Group
Germany Europe
Aenova Group Discover our facility

Headquarter - Location Starnberg

  • Activity: N/A manufacturing
  • Uses: N/A
  • Therapeutic areas: N/A
  • Certifications: N/A
  • Services: N/A
  • Batch Size / Reactor: N/A
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: N/A
Cambrex Waterford (Q1 Scientific)
Ireland Europe
Cambrex Waterford (Q1 Scientific) Discover our facility

Q1 Scientific Ltd., a Cambrex Company, provides environmentally controlled cGMP stability storage services for the pharmaceutical, medical device, and life science industries.

  • Activity: SERVICES manufacturing
  • Uses: N/A
  • Therapeutic areas: N/A
  • Certifications: N/A
  • Services: Storage, Stability studies design, Stability...
  • Batch Size / Reactor: N/A
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: N/A
Cambrex Liege (Q1 Scientific)
Belgium Europe
Cambrex Liege (Q1 Scientific) Discover our facility

Strategically located in the Li ge region of Belgium, the state-of-the-art cGMP facility provides ICH and custom conditions to meet the specific storage requirements of any pharmaceutical project, with options from -80°C storage up to +50°C, with a full range of humidity control.

  • Activity: SERVICES manufacturing
  • Uses: N/A
  • Therapeutic areas: N/A
  • Certifications: N/A
  • Services: Storage, Stability studies design, Stability...
  • Batch Size / Reactor: N/A
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: N/A
SERVICES in Europe
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Spain Europe
FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC COSMETICS NUTRACEUTICALS SERVICES in Europe Discover our facility

Chemical-Pharmaceutical Plant

  • Activity: CHEMICAL-SYNTHETIC, FDF / DRUG PRODUCTS,... manufacturing
  • Uses: N/A
  • Therapeutic areas: N/A
  • Certifications: N/A
  • Services: N/A
  • Batch Size / Reactor: N/A
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: N/A
FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC COSMETICS NUTRACEUTICALS SERVICES in Europe
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India APAC
CHEMICAL-SYNTHETIC NUTRACEUTICALS SERVICES in APAC Discover our facility

Your trusted CRO/CDMO Partner

  • Activity: CHEMICAL-SYNTHETIC, NUTRACEUTICALS, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO
  • Services: N/A
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: N/A
CHEMICAL-SYNTHETIC NUTRACEUTICALS SERVICES in APAC
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India APAC
FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC SERVICES in APAC Discover our facility

Specialized contract research solutions designed to accelerate your drug discovery and development programs with precision and expertise.

  • Activity: CHEMICAL-SYNTHETIC, FDF / DRUG PRODUCTS, SERVICES manufacturing
  • Uses: N/A
  • Therapeutic areas: N/A
  • Certifications: ISO
  • Services: R&D, Analytical methods development, Analytical...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: N/A
FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC SERVICES in APAC
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China APAC
CHEMICAL-SYNTHETIC in APAC Discover our facility

Purity: 99% , white to light yellow powder, Customizable

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (V09-10) Radiopharmaceuticals
  • Certifications: ISO
  • Services: Scale-up
  • Batch Size / Reactor: Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: NMPA (China), CDSCO (India)
Rodon Biologics
Portugal Europe
Rodon Biologics Discover our facility

Rodon Biologics provides excellence in the development of biopharmaceutical products for third parties.

  • Activity: Abs (Antibodies), BIOLOGICS, Peptide, protein,... manufacturing
  • Uses: Investigational
  • Therapeutic areas: N/A
  • Certifications: N/A
  • Services: Upstream, Downstream, Cell line development,...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Fed-batch
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2
  • Markets: N/A
BIOLOGICS NUTRACEUTICALS SERVICES in Europe
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Switzerland Europe
FDF / DRUG PRODUCTS COSMETICS NUTRACEUTICALS in Europe Discover our facility

Contract Service Unit of a Swiss Biopharmaceutical Company that identifies, develops, and markets novel products in rare and ultra-rare diseases globally.

  • Activity: Oral solids / OSD, Oral liquids and semisolids,... manufacturing
  • Uses: N/A
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP)
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: N/A
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: EMA (EU)
FDF / DRUG PRODUCTS COSMETICS NUTRACEUTICALS in Europe
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Spain Europe
SERVICES in Europe Discover our facility

We provide analytical services to support the pharmaceutical, biopharmaceutical, and chemical industries at every stage of drug development

  • Activity: SERVICES manufacturing
  • Uses: Investigational, Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: ISO, World Health Organization (GMP / HACCP)
  • Services: R&D, Analytical methods development,...
  • Batch Size / Reactor: N/A
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: EMA (EU)
White Raven - Legiapark
Belgium Europe
White Raven - Legiapark Discover our facility

Fill and finish site dedicated to GMP Formulation and the Aseptic filling of Sterile Liquid Injectables.

  • Activity: Injectables, FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II,...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP)
  • Services: Tech transfer, Primary packaging, Scale-up,...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2
  • Markets: EMA (EU)
Cambrex Wiesbaden
Germany Europe
Cambrex Wiesbaden Discover our facility

Our specialist team in Wiesbaden has strong expertise in enzyme screening and developed more than 800 proprietary enzymes of different classes.

  • Activity: BIOLOGICS, Peptide, protein, hormone & enzyme manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: N/A
  • Services: R&D, Analytical methods development, Storage,...
  • Batch Size / Reactor: Small, Medium, Large, 1 - 10 sqm, 10 - 50 sqm, 50...
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU)
BIOLOGICS in Europe
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Spain Europe
BIOLOGICS COSMETICS SERVICES in Europe Discover our facility

Fermentation Plant

  • Activity: ATMP (Advanced Therapies), Abs (Antibodies),... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO
  • Services: R&D, Upstream, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Medium, Fed-batch, 100 -...
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: N/A
CARBOGEN AMCIS | Manchester, UK
United Kingdom Europe
CARBOGEN AMCIS | Manchester, UK Discover our facility

Discover our cosmetic ingredient manufacturing capabilities, fine chemicals and custom synthesis of pharma intermediates capabilities

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: N/A
  • Therapeutic areas: N/A
  • Certifications: ISO, ECOVADIS, Halal Research Council
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: N/A
Cambrex Agawam
United States North America
Cambrex Agawam Discover our facility

Cambrex Agawam offers a full suite of microbiological, analytical, and environmental monitoring services to support pharmaceutical and medical device product development.

  • Activity: SERVICES manufacturing
  • Uses: N/A
  • Therapeutic areas: N/A
  • Certifications: ISO, FDA (cGMP)
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: N/A
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): N/A
  • BSL: 1
  • Markets: FDA (USA), EMA (EU)
CDM Lavoisier
France Europe
CDM Lavoisier Discover our facility

CDM Lavoisier is specialized in the manufacturing of glass ampoules, glass vials and plastic (BFS) ampoules.

  • Activity: Injectables, FDF / DRUG PRODUCTS manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP)
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: EMA (EU)
Aenova Group - Location Greensboro, USA
United States North America
Aenova Group - Location Greensboro, USA Discover our facility

Competence Center Packaging Solids.

  • Activity: NUTRACEUTICALS manufacturing
  • Uses: Investigational, Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: FDA (cGMP), Health Canada (Canada GMP), Halal...
  • Services: Primary packaging, Storage, Secondary packaging,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: FDA (USA), Health Canada (Canada)
NUTRACEUTICALS in North America
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Germany Europe
BIOLOGICS in Europe Discover our facility

Your trusted CDMO partner with more than 30 years experience in the development and manufacturing of biopharmaceuticals, viral vectors, and vaccines.

  • Activity: Cell therapy, ATMP (Advanced Therapies), GTMP... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: N/A
  • Services: Analytical methods development, R&D, Batch...
  • Batch Size / Reactor: Small, Batch, Medium, Fed-batch, Large, Perfusion
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2
  • Markets: N/A
Sylentis
Spain Europe
Sylentis Discover our facility

Oligonucleotide manufacturer

  • Activity: OLIGONUCLEOTIDES manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II,...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP)
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 3 (PDE = 100 - 1,000 µg/day)
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU)
ASCIL Biopharm
Spain Europe
ASCIL Biopharm Discover our facility

A GMP facility fully equipped for R&D and pharmaceutical development. Includes laboratories and a pilot plant for technical and clinical batches of sterile products.

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP)
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2
  • Markets: EMA (EU)
FDF / DRUG PRODUCTS in Europe
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United Kingdom Europe
FDF / DRUG PRODUCTS SERVICES in Europe Discover our facility

Lyos and liquids - Two Annex I compliant BSL-2 cleanroom suites, dedicated containment suite, Up to 50L bulk volume, Lyophilisation (x2) with gas overlay Up to 3,000 vials per batch. Temperature-controlled quarantine and storage of drug product GMP material management.

  • Activity: Injectables, FDF / DRUG PRODUCTS, SERVICES manufacturing
  • Uses: Investigational, Commercial (Phase IV), Phase I,...
  • Therapeutic areas: N/A
  • Certifications: FDA (cGMP), MHRA (UK GMP)
  • Services: CMC regulatory support, Tech transfer, Batch...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), MHRA (UK)
FDF / DRUG PRODUCTS SERVICES in Europe
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Germany Europe
FDF / DRUG PRODUCTS in Europe Discover our facility

Specialty pharmaceutical company focused on the research, development, and production of therapies in neurology and injectable treatments for oncology, intensive care, and hormones.

  • Activity: Injectables, FDF / DRUG PRODUCTS, Implants manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), PMDA/MHLW (Japan...
  • Services: N/A
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 2
  • Markets: N/A
VIVEbiotech
Spain Europe
VIVEbiotech Discover our facility

Your leading GMP-certified CDMO exclusively dedicated to the production of lentiviral vectors.

  • Activity: ATMP (Advanced Therapies), GTMP (Gene Therapy),... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), French Service-Public...
  • Services: Upstream, Downstream, Cell line development, Cell...
  • Batch Size / Reactor: Small, 1 - 100 L, Medium, 100 - 1000 L, Large,...
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2
  • Markets: N/A
VIVUNT PHARMA
Spain Europe
VIVUNT PHARMA Discover our facility

CDMO Sterile Oncology Drugs

  • Activity: Injectables, FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (L) Antineoplastic and immunomodulating agents
  • Certifications: EMA (EU GMP)
  • Services: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: EMA (EU)
Content Group | Pomezia Plant
Italy Europe
Content Group | Pomezia Plant Discover our facility

Tubilux Pharma: registered office; manufacturing facility

  • Activity: Sterile forms (ophtalmic, nasal, otic), Inhalation... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (S) Sensory organs
  • Certifications: EMA (EU GMP), FDA (cGMP), TGA (Australia GMP),...
  • Services: N/A
  • Batch Size / Reactor: Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), TGA (Australia), ANVISA...
Content Group | Rovereto s/S Plant
Italy Europe
Content Group | Rovereto s/S Plant Discover our facility

COC Farmaceutici srl: commercial and administrative headquarters; manufacturing facility

  • Activity: Sterile forms (ophtalmic, nasal, otic), Oral... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: ISO
  • Services: Batch certification / release, Primary packaging,...
  • Batch Size / Reactor: Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: EMA (EU), MHRA (UK), EDE (UAE), SFDA (Saudi...
FDF / DRUG PRODUCTS COSMETICS SERVICES in Europe
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FDF / DRUG PRODUCTS in Discover our facility

Specialty contract research and development laboratory (CRDO) based in USA that provides end-to-end pharmaceutical product development services. Topicals, Transdermals, Ophthalmics, Injectables, Inserts, OINDPs, Otics, Oral liquids etc.

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: N/A
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Batch certification / release, CMC regulatory...
  • Batch Size / Reactor: N/A
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Content Group | Sant Agata Bolognese
Italy Europe
Content Group | Sant Agata Bolognese Discover our facility

COC Farmaceutici srl: registered office; manufacturing facility

  • Activity: Sterile forms (ophtalmic, nasal, otic), Inhalation... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (R) Respiratory system, (S) Sensory organs
  • Certifications: ISO, EMA (EU GMP)
  • Services: Storage, R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: EMA (EU)
Ophtapharm, a Sentiss Company
Switzerland Europe
Ophtapharm, a Sentiss Company Discover our facility

Ophtalmic and Otic - Solutions, suspensions, emulsions, ointments and gels - FDA Approved facility

  • Activity: Sterile forms (ophtalmic, nasal, otic), FDF / DRUG... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: Analytical methods development, Primary packaging,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU)
Rioja Nature Pharma
Spain Europe
Rioja Nature Pharma Discover our facility

CDMO NUTRACEUTICALS/FOOD SUPPLEMENTS

  • Activity: NUTRACEUTICALS manufacturing
  • Uses: N/A
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), World Health...
  • Services: N/A
  • Batch Size / Reactor: Medium
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), NMPA (China), MHRA (UK),...
PHARMALOOP S.L. - a Salvat Company
Spain Europe
PHARMALOOP S.L. - a Salvat Company Discover our facility

Fully integrated CDMO solutions for Blow-Fill-Seal (BFS), sterile multidose, non-sterile multi-dose, sachets, capsules and tablets.

  • Activity: Sterile forms (ophtalmic, nasal, otic), Oral... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (S) Sensory organs, (V01) Allergens
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP)
  • Services: Primary packaging, CMC regulatory support, R&D,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
  • BSL: 1
  • Markets: FDA (USA), EMA (EU)
FDF / DRUG PRODUCTS PARTICLE ENGINEERING in Europe
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Ireland Europe
FDF / DRUG PRODUCTS BIOLOGICS COSMETICS in Europe Discover our facility

Contract Development & Manufacturing Organisation

  • Activity: Cell therapy, ATMP (Advanced Therapies),... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP)
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Medium, Fed-batch,...
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
FDF / DRUG PRODUCTS BIOLOGICS COSMETICS in Europe
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Spain Europe
NUTRACEUTICALS SERVICES PARTICLE ENGINEERING in Europe Discover our facility

HIPERING® TECHNOLOGY - THE GATEWAY FOR LEAN MANUFACTURING

  • Activity: PARTICLE ENGINEERING, NUTRACEUTICALS, SERVICES manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: R&D, Preformulation studies, Pilot plant,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU)
BAG Health Care
Germany Europe
BAG Health Care Discover our facility

Parenteral F&F provider for vials in small to mid sized batches.

  • Activity: Injectables, FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Commercial (Phase IV), Phase I,...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), World Health Organization (GMP /...
  • Services: Tech transfer, Batch certification / release,...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1
  • Markets: EMA (EU), MHRA (UK), TGA (Australia)
FDF / DRUG PRODUCTS in Europe
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Poland Europe
FDF / DRUG PRODUCTS BIOLOGICS in Europe Discover our facility

mRNA & LNP manufacturing, F&F

  • Activity: ATMP (Advanced Therapies), Injectables, GTMP (Gene... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP)
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Medium, 100 - 1000 L,...
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
  • BSL: 1
  • Markets: FDA (USA), EMA (EU), PMDA (Japan)
Cellex Cell Professionals
Germany Europe
Cellex Cell Professionals Discover our facility

CGT CDMO Cell Manufacturing Plant and Collection Center for Starting Materials

  • Activity: Cell therapy, ATMP (Advanced Therapies), GTMP... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP)
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU)
FDF / DRUG PRODUCTS BIOLOGICS SERVICES in Europe
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Portugal Europe
FDF / DRUG PRODUCTS BIOLOGICS in Europe Discover our facility

Commercial Scale Facility

  • Activity: Injectables, Abs (Antibodies), BIOLOGICS, Peptide,... manufacturing
  • Uses: Investigational, Commercial (Phase IV), Phase II,...
  • Therapeutic areas: (G) Genito urinary system and sex hormones, (J)...
  • Certifications: ISO, EMA (EU GMP), World Health Organization (GMP...
  • Services: Analytical methods development, R&D, Batch...
  • Batch Size / Reactor: Batch, 1 - 100 L, Medium, Fed-batch, 100 - 1000 L,...
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2
  • Markets: EMA (EU)
BDI biotech Production Plant
Spain Europe
BDI biotech Production Plant Discover our facility

We work as an R&D department specialized in strain and bioprocess development, scale-up and batches production.

  • Activity: BIOLOGICS, Peptide, protein, hormone & enzyme, LBP... manufacturing
  • Uses: Investigational, Preclinical
  • Therapeutic areas: N/A
  • Certifications: ISO
  • Services: CMC regulatory support, R&D, Upstream, Tech...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Medium, Fed-batch, 100 -...
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1
  • Markets: FDA (USA), EMA (EU), MHRA (UK), Health Canada...
Skyepharma
France Europe
Skyepharma Discover our facility

EXPERT AND INNOVATIVE CDMO COMPLEX ORAL SOLIDS: Fully integrated french CDMO Skyepharma is a key player in drug development and delivery of oral technologies serving the global pharmaceutical, biotech and consumer health industries.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), World Health...
  • Services: Storage, R&D, Tech transfer, Primary packaging,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), MFDS (South Korea), ANVISA...
FDF / DRUG PRODUCTS in Europe
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Spain Europe
FDF / DRUG PRODUCTS BIOLOGICS in Europe Discover our facility

Clinical Trials Facility

  • Activity: Cell therapy, ATMP (Advanced Therapies),... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II,...
  • Therapeutic areas: (A) Digestive tract and metabolism, (G) Genito...
  • Certifications: ISO, EMA (EU GMP), World Health Organization (GMP...
  • Services: Analytical methods development, R&D, Batch...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 2
  • Markets: EMA (EU), CDSCO (India), ANVISA (Brazil)
FDF / DRUG PRODUCTS BIOLOGICS in Europe
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Germany Europe
FDF / DRUG PRODUCTS in Europe Discover our facility

End-to-End Pharma CDMO

  • Activity: Injectables, FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: N/A
  • Services: Batch certification / release, Primary packaging,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
FDF / DRUG PRODUCTS in Europe
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Netherlands Europe
FDF / DRUG PRODUCTS in Europe Discover our facility

We can take your pharmaceuticals from lab scale to the early clinical phase and beyond. Our state-of-the-art facility, with GMP-compliant clean rooms, is well equipped to offer a wide range of analytical testing and regulatory support. These services are tailored to your specific needs, implementing the relevant quality guidelines at every step along the way.

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II,...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP)
  • Services: Primary packaging, Storage, CMC regulatory...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), MHRA (UK), TGA (Australia)
FDF / DRUG PRODUCTS in Europe
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Spain Europe
FDF / DRUG PRODUCTS BIOLOGICS in Europe Discover our facility

Single Use Commercial Scale Facility

  • Activity: Injectables, Abs (Antibodies), BIOLOGICS, Peptide,... manufacturing
  • Uses: Investigational, Commercial (Phase IV), Phase III
  • Therapeutic areas: (G) Genito urinary system and sex hormones, (J)...
  • Certifications: ISO, EMA (EU GMP), World Health Organization (GMP...
  • Services: Batch certification / release, Primary packaging,...
  • Batch Size / Reactor: Batch, 1 - 100 L, Medium, Fed-batch, 100 - 1000 L,...
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2
  • Markets: EMA (EU)
Viswa Laboratories Pvt Ltd
India APAC
Viswa Laboratories Pvt Ltd Discover our facility

CRAMS/CDMO, APIs, Intermediates and specialty chemicals

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (C) Cardiovascular system, (D) Dermatologicals,...
  • Certifications: World Health Organization (GMP / HACCP)
  • Services: R&D, Tech transfer, Pilot plant, Scale-up, Clean...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: Lower potential for abuse
  • Toxicity (OEB classification): 3 (PDE = 100 - 1,000 µg/day)
  • BSL: 2
  • Markets: EMA (EU), NMPA (China), CDSCO (India), ANVISA...
Aenova Group - Location Bad Aibling, Germany
Germany Europe
Aenova Group - Location Bad Aibling, Germany Discover our facility

Competence Center Blister packaging Third party packaging High volume plant for effervescents.

  • Activity: Oral solids / OSD, Oral liquids and semisolids,... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), IFS
  • Services: R&D, Tech transfer, Primary packaging, Secondary...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU)
Aenova Group - Location Cornu, Romania
Romania Europe
Aenova Group - Location Cornu, Romania Discover our facility

Competence Center and one-stop shop for Soft gelatin capsules and VegaGels®.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS,... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Primary packaging, Secondary packaging, Labeling,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), Health Canada (Canada), TGA (Australia)
Liof Pharma S.L.U.
Spain Europe
Liof Pharma S.L.U. Discover our facility

Reliable CDMO partner for aseptic manufacturing and lyophilization of biologics and injectable drugs.

  • Activity: FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: Batch certification / release, Primary packaging,...
  • Batch Size / Reactor: N/A
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1
  • Markets: FDA (USA), EMA (EU), MHRA (UK), ANVISA (Brazil),...
Aenova Group - Location Carugate, Italy
Italy Europe
Aenova Group - Location Carugate, Italy Discover our facility

Competence Center Semisolids and non-sterile liquids.

  • Activity: Oral liquids and semisolids, FDF / DRUG PRODUCTS,... manufacturing
  • Uses: N/A
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), Roszdravnadzor (Russia GMP),...
  • Services: Primary packaging, Secondary packaging, Labeling,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: EMA (EU), SFDA (Saudi Arabia), ANVISA (Brazil),...
Aenova Group - Location Marburg, Germany
Germany Europe
Aenova Group - Location Marburg, Germany Discover our facility

Competence Center complex conventional solids and narcotics.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: Tech transfer, Primary packaging, Secondary...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), ANVISA (Brazil), Russian...
FDF / DRUG PRODUCTS NUTRACEUTICALS in Europe
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Germany Europe
FDF / DRUG PRODUCTS in Europe Discover our facility

Semi-solid and non-sterile liquid pharmaceuticals. With over 100 years of experience, we have a track record of providing first class service and customer focused manufacturing.

  • Activity: Oral liquids and semisolids, FDF / DRUG PRODUCTS,... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP)
  • Services: Storage, Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: High potential for abuse & medical use, Lower...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK),...
Aenova Group - Location Killorglin, Ireland
Ireland Europe
Aenova Group - Location Killorglin, Ireland Discover our facility

Competence Center for spray drying and modified release pellets.

  • Activity: Oral solids / OSD, PARTICLE ENGINEERING, FDF /... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), MFDS/KFDA (Republic of Korea...
  • Services: Tech transfer, Scale-up
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: EMA (EU), PMDA (Japan), MFDS (South Korea), SFDA...
Cambrex Waltham (Snapdragon Chemistry)
United States North America
Cambrex Waltham (Snapdragon Chemistry) Discover our facility

Our team members with Snapdragon Chemistry Inc., a Cambrex Company, specialize in chemical process development and manufacturing services, leveraging state-of-the-art technology to optimize your process and prepare scaled quantities of your product.

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
CHEMICAL-SYNTHETIC in North America
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Switzerland Europe
FDF / DRUG PRODUCTS BIOLOGICS in Europe Discover our facility

We specialize in aseptic manufacturing of lyophilized or liquid sterile (bio)pharmaceutical drug products through fill and finish.

  • Activity: Injectables, BIOLOGICS, Peptide, protein, hormone... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP)
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
FDF / DRUG PRODUCTS BIOLOGICS in Europe
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Canada North America
FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC SERVICES in North America Discover our facility

Pharma CRO/CMO

  • Activity: CHEMICAL-SYNTHETIC, FDF / DRUG PRODUCTS, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (C) Cardiovascular system, (D) Dermatologicals,...
  • Certifications: ISO, FDA (cGMP), World Health Organization (GMP /...
  • Services: R&D, Tech transfer, Preformulation studies, Pilot...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), CDSCO (India), ANVISA...
Laboratori Alchemia SRL
Italy Europe
Laboratori Alchemia SRL Discover our facility

Our facilities are designed to satisfy production requirements ranging from laboratory scale for synthetically complex products or those which are even unknown in literature, to production levels of several hundred kilograms per year.

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: N/A
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), World Health Organization (GMP /...
  • Services: Batch certification / release, Primary packaging,...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK),...
Aenova Group - Location Feldkirchen, Germany
Germany Europe
Aenova Group - Location Feldkirchen, Germany Discover our facility

Competence Center Semisolids and Liquids.

  • Activity: Oral liquids and semisolids, FDF / DRUG PRODUCTS,... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (D) Dermatologicals, (J) Antiinfectives for...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Roszdravnadzor...
  • Services: R&D, Tech transfer, Primary packaging, Secondary...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), Russian Health Authorities
FDF / DRUG PRODUCTS COSMETICS in Europe
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Italy Europe
FDF / DRUG PRODUCTS in Europe Discover our facility

Oral forms (liquid & solid)

  • Activity: Oral solids / OSD, Oral liquids and semisolids,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), World Health Organization (GMP...
  • Services: R&D, Tech transfer, Preformulation studies, Pilot...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: EMA (EU), MHRA (UK), MFDS (South Korea), Russian...
Cultiply
Spain Europe
Cultiply Discover our facility

Spanish CDMO that develops production and purification processes for recombinant proteins, enzymes, DNA and other bioderived products.

  • Activity: Abs (Antibodies), BIOLOGICS, ADC & NDC... manufacturing
  • Uses: Investigational, Preclinical
  • Therapeutic areas: N/A
  • Certifications: ISO
  • Services: R&D, Upstream, Tech transfer, Downstream, Pilot...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Medium, Fed-batch, 100 -...
  • Controlled substance: Lowest potential for abuse
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Aenova Group - Location Sisseln, Switzerland
Switzerland Europe
Aenova Group - Location Sisseln, Switzerland Discover our facility

Competence Center complex conventional solids.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, FDA (cGMP), World Health Organization (GMP /...
  • Services: Tech transfer, Primary packaging, Secondary...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), MFDS (South Korea), Turkish Health...
Aenova Group - Location Tittmoning, Germany
Germany Europe
Aenova Group - Location Tittmoning, Germany Discover our facility

Competence Center conventional solids high volume plant.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS,... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Primary packaging, Secondary packaging, Labeling,...
  • Batch Size / Reactor: Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), Health Canada (Canada), TGA...
Cambrex Longmont
United States North America
Cambrex Longmont Discover our facility

Cambrex Longmont location specializes in the early development of small molecule pharmaceutical products in a fully integrated drug substance and drug product facility.

  • Activity: CHEMICAL-SYNTHETIC, Oral solids / OSD, Oral... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
CARBOGEN AMCIS | Vionnaz
Switzerland Europe
CARBOGEN AMCIS | Vionnaz Discover our facility

Highly Potent APIs development and small-scale cGMP production including chromatography and lyophilization

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II,...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: R&D, Analytical methods development, Batch...
  • Batch Size / Reactor: Small
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Sidefarma
Portugal Europe
Sidefarma Discover our facility

Sidefarma is a CMO specialized in the manufacture of small and medium size batches for pharmaceutical companies across the world in regulated markets following European quality.

  • Activity: Oral solids / OSD, Oral liquids and semisolids,... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), UAE Ministry of Health &...
  • Services: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: High potential for abuse & medical use, Lower...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: EMA (EU), PMDA (Japan), MHRA (UK), Health Canada...
FDF / DRUG PRODUCTS in Europe
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United Kingdom Europe
CHEMICAL-SYNTHETIC SERVICES in Europe Discover our facility

R&D Centre

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: Investigational, Preclinical
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: N/A
  • Services: R&D, Process development, Process optimization
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: High potential for abuse & no medical use
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: N/A
Aenova Group - Location Gronau, Germany
Germany Europe
Aenova Group - Location Gronau, Germany Discover our facility

Competence center for conventional solids and clinical services.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), EDE (UAE),...
CARBOGEN AMCIS | Aarau
Switzerland Europe
CARBOGEN AMCIS | Aarau Discover our facility

Development and medium scale cGMP manufacturing including chromatography

  • Activity: CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, FDA (cGMP), World Health Organization (GMP /...
  • Services: Batch certification / release, R&D, Tech transfer,...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Kemwell Biopharma Pvt Ltd
India APAC
Kemwell Biopharma Pvt Ltd Discover our facility

Kemwell is a biologics focused Contract Development and Manufacturing (CDMO) company providing services to global biopharmaceutical organisations

  • Activity: Abs (Antibodies), BIOLOGICS, Peptide, protein,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, FDA (cGMP), World Health Organization (GMP /...
  • Services: Analytical methods development, R&D, Batch...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Medium, Fed-batch, 100 -...
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2, 3, 4
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
AdhexPharma SAS
France Europe
AdhexPharma SAS Discover our facility

CDMO for transdermal patches and oromucosal films

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS, Topical,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (D) Dermatologicals, (H) Systemic hormonal...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP)
  • Services: Analytical methods development, R&D, Tech...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: High potential for abuse & medical use, Lower...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
Green Phoenix Labs GmbH
Germany Europe
Green Phoenix Labs GmbH Discover our facility

Cell Therapy company with excess Cleanroom capacity

  • Activity: Cell therapy, ATMP (Advanced Therapies),... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: EMA (EU GMP)
  • Services: Batch certification / release, Primary packaging,...
  • Batch Size / Reactor: Small, Batch, Medium
  • Controlled substance: Low potential for abuse, Lowest potential for...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1
  • Markets: EMA (EU)
Cambrex Durham
United States North America
Cambrex Durham Discover our facility

Cambrex Durham is our analytical center of excellence, supporting testing across the entire drug development lifecycle.

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Batch certification / release, Storage, CMC...
  • Batch Size / Reactor: Small
  • Controlled substance: High potential for abuse & medical use, Lower...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
Cambrex Edinburgh
United Kingdom Europe
Cambrex Edinburgh Discover our facility

Cambrex Edinburgh offers world-class solid form screening programs, including salt screening, polymorph screening, co-crystal screening, crystallization screening, and further specialized screening activities.

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: N/A
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: N/A
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
Cambrex Milan
Italy Europe
Cambrex Milan Discover our facility

Our Cambrex Milan site develops and manufactures proprietary products (generic APIs) and provides contract manufacturing services for intermediates and custom APIs at commercial scale.

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Commercial (Phase IV), Phase II,...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Medium, Large
  • Controlled substance: Low potential for abuse, Lowest potential for...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
CARBOGEN AMCIS | Neuland
Switzerland Europe
CARBOGEN AMCIS | Neuland Discover our facility

Development and medium scale manufacturing

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: FDA (cGMP), World Health Organization (GMP /...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
CHEMICAL-SYNTHETIC SERVICES in Europe
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Belgium Europe
CHEMICAL-SYNTHETIC SERVICES in Europe Discover our facility

Trasis is committed to the development of cutting-edge solutions that help improve the diagnosis and treatment of major diseases among which cancers, neurological and cardiological diseases. This with API synthesis, formulation development and (GMP) manufacturing combined with fill and finish capabilities

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (C) Cardiovascular system, (L) Antineoplastic and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP)
  • Services: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2, 3, 4
  • Markets: FDA (USA), EMA (EU), TGA (Australia)
CHEMICAL-SYNTHETIC SERVICES in Europe
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United Kingdom Europe
CHEMICAL-SYNTHETIC SERVICES in Europe Discover our facility

R&D and GMP manufacturing site, Bowburn, Durham, UK

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, MHRA (UK GMP)
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: High potential for abuse & no medical use
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: N/A
Cambrex Karlskoga
Sweden Europe
Cambrex Karlskoga Discover our facility

Cambrex Karlskoga features a wide range of flexible manufacturing facilities, including kilo-scale, pilot-scale, and large-scale commercial production plants.

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Commercial (Phase IV), Phase II,...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Medium, Large
  • Controlled substance: High potential for abuse & medical use, Lower...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
Cambrex Tallinn
Estonia Europe
Cambrex Tallinn Discover our facility

Our team in Tallin has strong expertise in custom organic syntheses and contract R&D for pharmaceutical and fine chemical industries.

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
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Australia APAC
FDF / DRUG PRODUCTS SERVICES PARTICLE ENGINEERING in APAC Discover our facility

Boronia, VIC, Australia

  • Activity: Injectables, Oral solids / OSD, Oral liquids and... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (C) Cardiovascular system, (L) Antineoplastic and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: Analytical methods development, Primary packaging,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada...
FDF / DRUG PRODUCTS SERVICES PARTICLE ENGINEERING in APAC
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France Europe
FDF / DRUG PRODUCTS in Europe Discover our facility

Sterile liquids and suppositories manufacturing. We handle more than 100 molecules and provide stability studies, narcotics handling and analytical testing services.

  • Activity: Injectables, FDF / DRUG PRODUCTS, Topical, mucosal... manufacturing
  • Uses: Investigational, Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
  • Services: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK),...
53Biologics Production Plant
Spain Europe
53Biologics Production Plant Discover our facility

53Biologics is a Spanish CDMO specialized in decoding biologics production, from DNA to proteins, providing from preclinical to cGMP manufacturing.

  • Activity: Abs (Antibodies), BIOLOGICS, ADC & NDC... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Medium, Fed-batch, 100 -...
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU), MHRA (UK), Health Canada...
Mabion cGMP Facility
Poland Europe
Mabion cGMP Facility Discover our facility

Mabion is a fully integrated CDMO offering a wide services associated with the development and GMP manufacturing of biotherapeutics, including monoclonal antibodies and any recombinant protein-based products.

  • Activity: Abs (Antibodies), BIOLOGICS, ADC & NDC... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: Analytical methods development, R&D, Batch...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Medium, 100 - 1000 L,...
  • Controlled substance: Lowest potential for abuse
  • Toxicity (OEB classification): 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10...
  • BSL: 1, 2, 3
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
BIOLOGICS in Europe
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France Europe
FDF / DRUG PRODUCTS in Europe Discover our facility

Accueil Sites Osny. Acquired in 2011, the Osny site specializes in the development and production of highly active solid pharmaceutical forms (hormonal and allergens). This 4,000 m2 pharmaceutical plant located 36 km northwest of Paris employs around a hundred people.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (G) Genito urinary system and sex hormones, (H)...
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Aenova Group - Location Münster, Germany
Germany Europe
Aenova Group - Location Münster, Germany Discover our facility

Competence Center low-dosed high potent solids (hormones, hormone-like), low-dosed capsules.

  • Activity: Oral solids / OSD, Inhalation products, FDF / DRUG... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (H) Systemic hormonal preparations excl. sex...
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: Primary packaging, Secondary packaging, Labeling,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), MFDS (South Korea), Turkish...
Cambrex High Point
United States North America
Cambrex High Point Discover our facility

Cambrex High Point focuses on the development and manufacture of active pharmaceutical ingredients (APIs) to support clinical trials from Phase I to Phase III, as well as small-scale commercial manufacturing.

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Commercial (Phase IV), Phase I,...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
CHEMICAL-SYNTHETIC in North America
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Japan APAC
FDF / DRUG PRODUCTS SERVICES in APAC Discover our facility

Our facility provides best-in-class manufacturing of tablets and ampoules, English and Japanese outstanding customer service, and has more than 330 high skilled employees. It stands out as one of Japan largest cold storage warehouses.

  • Activity: Injectables, Oral solids / OSD, FDF / DRUG... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), PMDA/MHLW (Japan GMP)
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Large
  • Controlled substance: High potential for abuse & medical use, Lower...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
FDF / DRUG PRODUCTS SERVICES in APAC
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Lithuania Europe
FDF / DRUG PRODUCTS BIOLOGICS SERVICES in Europe Discover our facility

Global End-to-End Biologics CDMO

  • Activity: ATMP (Advanced Therapies), Injectables, GTMP (Gene... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), French...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Medium, Fed-batch, 100 -...
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
  • BSL: 1, 2, 3
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
FDF / DRUG PRODUCTS BIOLOGICS SERVICES in Europe
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United States North America
FDF / DRUG PRODUCTS BIOLOGICS SERVICES in North America Discover our facility

Contract Development and Manufacturing Organization (CDMO) with a focus on recombinant proteins and monoclonal antibodies (mAbs).

  • Activity: Abs (Antibodies), BIOLOGICS, Peptide, protein,... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: N/A
  • Services: Analytical methods development, R&D, Upstream,...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Medium, Fed-batch, 100 -...
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU)
Actylis Eugene
United States North America
Actylis Eugene Discover our facility

Chemical Process Discovery, Development, cGMP, and Commerical Manufacturing Services.

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, FDA (cGMP)
  • Services: Batch certification / release, CMC regulatory...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: Lower potential for abuse, Low potential for...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), MHRA (UK), Health Canada...
Aenova Group - Location Latina, Italy
Italy Europe
Aenova Group - Location Latina, Italy Discover our facility

Competence Center animal health products and sterile technologies.

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: CMC regulatory support, R&D, Tech transfer,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU), Turkish Health Authorities,...
FDF / DRUG PRODUCTS BIOLOGICS in Europe
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United States North America
FDF / DRUG PRODUCTS in North America Discover our facility

Research and Development Services, Analytical Services, Technology Transfer and New Product Introduction, and Manufacturing Services in the field of solid and liquid oral dosage forms.

  • Activity: Oral solids / OSD, Oral liquids and semisolids,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, FDA (cGMP), World Health Organization (GMP /...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 3 (PDE = 100 - 1,000 µg/day)
  • BSL: 1
  • Markets: FDA (USA)
FDF / DRUG PRODUCTS in North America
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China APAC
FDF / DRUG PRODUCTS BIOLOGICS in APAC Discover our facility

Integrated development and cGMP manufacturing site

  • Activity: Injectables, Abs (Antibodies), BIOLOGICS, ADC &... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II,...
  • Therapeutic areas: N/A
  • Certifications: NMPA (China GMP)
  • Services: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Medium, Fed-batch, 100 -...
  • Controlled substance: Lowest potential for abuse
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Cambrex Charles City
United States North America
Cambrex Charles City Discover our facility

Our 400+ team members in Charles City specialize in late-phase and commercial API development and cGMP manufacturing.

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
CHEMICAL-SYNTHETIC in North America
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United Kingdom Europe
FDF / DRUG PRODUCTS BIOLOGICS SERVICES OLIGONUCLEOTIDES in Europe Discover our facility

Development and manufacturing of oral solid dose (OSD), nasal, inhalation, and sterile dry powders and liquids drug products.

  • Activity: Injectables, Abs (Antibodies), Sterile forms... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (C) Cardiovascular system, (N) Nervous system, (R)...
  • Certifications: MHRA (UK GMP)
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1
  • Markets: FDA (USA), EMA (EU), MHRA (UK), Health Canada...
Glatt Pharmaceutical Services GmbH Co. & KG
Germany Europe
Glatt Pharmaceutical Services GmbH Co. & KG Discover our facility

Your cGMP-compliant CDMO for end-to-end services in the complex oral solids dosage forms field, based in Binzen Germany

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Commercial (Phase IV), Phase I,...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: EMA (EU GMP), FDA (cGMP)
  • Services: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1
  • Markets: FDA (USA), EMA (EU)
ChemCon GmbH
Germany Europe
ChemCon GmbH Discover our facility

Contract development and manufacturing partner located in Germany for APIs and fine chemicals specialized in transferring R&D projects into fully cGMP-compliant manufacturing processes.

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (C) Cardiovascular system, (N) Nervous system, (R)...
  • Certifications: EMA (EU GMP), FDA (cGMP), ECOVADIS
  • Services: CMC regulatory support, R&D, Tech transfer,...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: High potential for abuse & medical use, Lower...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
CHEMICAL-SYNTHETIC in Europe
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France Europe
FDF / DRUG PRODUCTS in Europe Discover our facility

The Hérouville-Saint-Clair site, located near Caen, in Normandy, specializes in the manufacture and filling of injectable and non-injectable sterile liquid products. It has a pharmaceutical surface area of 17,900 m2 over 10 hectares and employs 290 people.

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Investigational, Commercial (Phase IV), Phase III
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: EMA (EU GMP), FDA (cGMP), NMPA (China GMP), ANVISA...
  • Services: Tech transfer, Batch certification / release,...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Aenova Group - Location Regensburg, Germany
Germany Europe
Aenova Group - Location Regensburg, Germany Discover our facility

Competence Center high potent solids (oncology) conventional solids - specialty semisolids & liquids.

  • Activity: Oral solids / OSD, Oral liquids and semisolids,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MFDS (South...
Darnytsia Kyiv
Ukraine Europe
Darnytsia Kyiv Discover our facility

CMO combining advanced facilities, stringent quality control, and expert staff to deliver reliable, compliant, and innovative solutions for its clients.

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Investigational, Commercial (Phase IV)
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), World Health Organization (GMP...
  • Services: Tech transfer, Batch certification / release,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
  • BSL: N/A
  • Markets: EMA (EU), NMPA (China), TGA (Australia), CDSCO...
Pharmaron API Commercial Synthesis Shaoxing (China)
China APAC
Pharmaron API Commercial Synthesis Shaoxing (China) Discover our facility

Commercial API Small Molecules /Peptides Synthesis

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, FDA (cGMP), NMPA (China GMP)
  • Services: Batch certification / release, CMC regulatory...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), NMPA (China)
Laboratorio REIG JOFRE, SA (TOLEDO PLANTS)
Spain Europe
Laboratorio REIG JOFRE, SA (TOLEDO PLANTS) Discover our facility

Betalactam antibiotics (FDF) development and manufacturing state-of-the-art facilities.

  • Activity: Injectables, Oral solids / OSD, Oral liquids and... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (J) Antiinfectives for systemic use
  • Certifications: EMA (EU GMP), Health Canada (Canada GMP),...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Medium, Large
  • Controlled substance: Lowest potential for abuse
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1
  • Markets: EMA (EU), MHRA (UK), TGA (Australia), SFDA (Saudi...
FDF / DRUG PRODUCTS in Europe
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France Europe
FDF / DRUG PRODUCTS in Europe Discover our facility

GMP plant on a four-hectare site is located 9 km east of Paris. It is a center of excellence for injectable ampoules.

  • Activity: Injectables, Oral solids / OSD, FDF / DRUG... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: EMA (EU GMP), FDA (cGMP), NMPA (China GMP), ANVISA...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: High potential for abuse & no medical use
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Apeloa Pharmaceutical Co., Ltd.
China APAC
Apeloa Pharmaceutical Co., Ltd. Discover our facility

Apeloa CDMO provides world-class discovery, development, and manufacturing services for Active Pharmaceutical Ingredients (APIs), Intermediates, and Registered Starting Materials (RSMs).

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), ECOVADIS, World...
  • Services: Primary packaging, R&D, Tech transfer, Analytical...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
HISTOCELL S.L. | Cell Therapy, Exosomes & Secretomes
Spain Europe
HISTOCELL S.L. | Cell Therapy, Exosomes & Secretomes Discover our facility

Histocell is a Spanish CDMO that develops and manufactures cell therapies from iPSCs, MSCs, secretomes, exosomes and other type of cells, as well medical devices and dermocosmetics.

  • Activity: Cell therapy, ATMP (Advanced Therapies),... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II,...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP)
  • Services: Analytical methods development, R&D, Batch...
  • Batch Size / Reactor: Small, 1 - 100 L, Medium
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
FDF / DRUG PRODUCTS BIOLOGICS COSMETICS SERVICES in Europe
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United States North America
CHEMICAL-SYNTHETIC in North America Discover our facility

The CDMO company designs, develops, and manufactures new chemical entities to treat human disease. Our cGMP suites support startups to global enterprises across clinical and commercial API production. Scientist-led and regulatory-savvy, we guide you through IND, CMC, ICH, FDA, and ISO challenges.

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, FDA (cGMP), NSF
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2
  • Markets: FDA (USA)
Ascendia Pharmaceutical Solutions
United States North America
Ascendia Pharmaceutical Solutions Discover our facility

Your trusted GMP CDMO for advanced aseptic and non-aseptic pharmaceutical drug product manufacturing, formulation development, and analytical testing.

  • Activity: Injectables, CHEMICAL-SYNTHETIC, Sterile forms... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: N/A
  • Services: Analytical methods development, R&D, Tech...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: High potential for abuse & medical use, Lower...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), Health Canada (Canada)
Grifols International | Murcia Plant
Spain Europe
Grifols International | Murcia Plant Discover our facility

Sterile manufacturing solutions (small molecules) in flexible bags

  • Activity: Injectables, FDF / DRUG PRODUCTS manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Primary packaging, Storage, Parametric release,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: Lower potential for abuse, Low potential for...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), TGA (Australia), MFDS (South...
FDF / DRUG PRODUCTS in Europe
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China APAC
FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC BIOLOGICS COSMETICS NUTRACEUTICALS OLIGONUCLEOTIDES in APAC Discover our facility

One-stop CDMO Solutions for APl and Key intermediates.

  • Activity: ATMP (Advanced Therapies), Injectables,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, FDA (cGMP), World Health Organization (GMP /...
  • Services: R&D, Pilot plant, Scale-up, Formulation mixing,...
  • Batch Size / Reactor: Batch, 1 - 100 L, Fed-batch, 100 - 1000 L, Large,...
  • Controlled substance: Lower potential for abuse, Low potential for...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
  • BSL: 1, 2, 3, 4
  • Markets: NMPA (China)
FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC BIOLOGICS COSMETICS NUTRACEUTICALS OLIGONUCLEOTIDES in APAC
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India APAC
CHEMICAL-SYNTHETIC COSMETICS NUTRACEUTICALS SERVICES in APAC Discover our facility

Small molecule drug substance development and manufacturing site

  • Activity: CHEMICAL-SYNTHETIC, COSMETICS, NUTRACEUTICALS,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: EMA (EU GMP), FDA (cGMP), MFDS/KFDA (Republic of...
  • Services: Analytical methods development, R&D, Tech...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK), MFDS...
Aenova Group - Location Kirchberg, Switzerland
Switzerland Europe
Aenova Group - Location Kirchberg, Switzerland Discover our facility

Competence Center Soft gelatin capsules.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS, COSMETICS,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: R&D, Tech transfer, Primary packaging, Secondary...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), TGA (Australia), MFDS (South...
HIPRA BIOTECH SERVICES | Aiguaviva
Spain Europe
HIPRA BIOTECH SERVICES | Aiguaviva Discover our facility

End-to-end internal capabilities from cell line development to commercial manufacturing.

  • Activity: Abs (Antibodies), BIOLOGICS, Peptide, protein,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Analytical methods development, R&D, Batch...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Medium, Fed-batch, 100 -...
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
Pharmaron API Commercial Synthesis Coventry (US)
United States North America
Pharmaron API Commercial Synthesis Coventry (US) Discover our facility

Commercial API Small Molecules Synthesis

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, FDA (cGMP), ECOVADIS
  • Services: Tech transfer, Pilot plant, Scale-up, Process...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
CHEMICAL-SYNTHETIC in North America
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Italy Europe
CHEMICAL-SYNTHETIC COSMETICS NUTRACEUTICALS SERVICES in Europe Discover our facility

Small molecule drug substance development and manufacturing site

  • Activity: CHEMICAL-SYNTHETIC, COSMETICS, NUTRACEUTICALS,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: EMA (EU GMP), FDA (cGMP), MFDS/KFDA (Republic of...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK), MFDS...
CHEMICAL-SYNTHETIC COSMETICS NUTRACEUTICALS SERVICES in Europe
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India APAC
CHEMICAL-SYNTHETIC COSMETICS NUTRACEUTICALS SERVICES in APAC Discover our facility

Small molecule drug substance development and manufacturing site

  • Activity: CHEMICAL-SYNTHETIC, COSMETICS, NUTRACEUTICALS,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: EMA (EU GMP), FDA (cGMP), MFDS/KFDA (Republic of...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK), MFDS...
HIPRA BIOTECH SERVICES | Amer
Spain Europe
HIPRA BIOTECH SERVICES | Amer Discover our facility

End-to-end internal capabilities from cell line development to commercial manufacturing

  • Activity: Injectables, Abs (Antibodies), BIOLOGICS, Peptide,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Analytical methods development, R&D, Batch...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Medium, Fed-batch, 100 -...
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
FDF / DRUG PRODUCTS BIOLOGICS in Europe
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Germany Europe
FDF / DRUG PRODUCTS SERVICES in Europe Discover our facility

Specializes in the development of Value Added Medicines and has been recently upgraded with HPAPI capabilities.

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: High potential for abuse & medical use
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Seda Pharma Development Services
United Kingdom Europe
Seda Pharma Development Services Discover our facility

Seda Pharmaceutical Development Services specialises in integrated Pharmaceutical Development and Clinical Pharmacology. Our mission is to facilitate the efficient development of optimal medicinal products, ranging from conventional to complex formulations, by leveraging scientific excellence. We are experts in all facets of dose selection and justification, including Drug Metabolism and Pharmacokinetics (DMPK), Clinical Pharmacology, Pharmaceutical Development, IND-NDA technical authoring, and GMP manufacturing. Our comprehensive suite of services encompasses consultancy, laboratory analysis, pharmacokinetic modelling and GMP manufacturing. This expertise enables us to guide clients through the entire drug development process, from initial discovery and preclinical studies to clinical trials and regulatory approval. Our focus is on designing and developing products that exhibit superior in vivo performance, robust manufacturability, and strong commercial potential. Based in Greater Manchester, UK, our cutting-edge facilities are equipped to support the rapid design, development, evaluation, and production of innovative formulations. By enhancing the value proposition of our global clients, we contribute to the advancement of new therapies, ultimately benefiting patients worldwide Expertise: Oral Drug Delivery DMPK Consultancy and Dose Selection Pharmacokinetic Modelling Complex Medicines Paediatric Product Development CMC Regulatory Clinical Pharmacology

  • Activity: Injectables, Oral solids / OSD, Oral liquids and... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ECOVADIS, MHRA (UK GMP)
  • Services: Batch certification / release, Primary packaging,...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Lannett CDMO
United States North America
Lannett CDMO Discover our facility

Lannetts main manufacturing site sits in Seymour, Indiana, and includes capabilities for Oral Solid Dose (OSD) and Liquids.

  • Activity: Oral solids / OSD, Oral liquids and semisolids,... manufacturing
  • Uses: Investigational, Commercial (Phase IV), Phase II,...
  • Therapeutic areas: (C) Cardiovascular system, (H) Systemic hormonal...
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Batch certification / release, Primary packaging,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Laboratorio REIG JOFRE, SA (BARCELONA PLANT)
Spain Europe
Laboratorio REIG JOFRE, SA (BARCELONA PLANT) Discover our facility

Injectable (lyo and liquid) and Liquid manufacturing facilities

  • Activity: Injectables, Oral liquids and semisolids, FDF /... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: EMA (EU GMP), Health Canada (Canada GMP),...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Medium, Large
  • Controlled substance: Lower potential for abuse, Low potential for...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2, 3
  • Markets: EMA (EU), PMDA (Japan), MHRA (UK), Health Canada...
Grifols International | Barcelona Plant
Spain Europe
Grifols International | Barcelona Plant Discover our facility

Sterile manufacturing solutions (small molecules) in flexible bags and vials.

  • Activity: Injectables, FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: Lower potential for abuse, Low potential for...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
FDF / DRUG PRODUCTS in Europe
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India APAC
FDF / DRUG PRODUCTS NUTRACEUTICALS SERVICES OLIGONUCLEOTIDES PARTICLE ENGINEERING in APAC Discover our facility

An USFDA approved API & Intermediate Manufacturing facility.

  • Activity: OLIGONUCLEOTIDES, PARTICLE ENGINEERING, FDF / DRUG... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, FDA (cGMP)
  • Services: Tech transfer, Pilot plant, Scale-up, Research...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2, 3, 4
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
FDF / DRUG PRODUCTS NUTRACEUTICALS SERVICES OLIGONUCLEOTIDES PARTICLE ENGINEERING in APAC
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Norway Europe
FDF / DRUG PRODUCTS in Europe Discover our facility

We specialize in the manufacturing of IV bags, plastic ampoules and vials using Blow-Fill-Seal (BFS) technology and other dosage forms.

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (D)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: CMC regulatory support, Analytical methods...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: High potential for abuse & medical use, Lower...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
FDF / DRUG PRODUCTS in Europe
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Belgium Europe
FDF / DRUG PRODUCTS SERVICES in Europe Discover our facility

Drug product formulation development and GMP manufacturing (clinical phase)

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II,...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), French Service-Public (CIR),...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
FDF / DRUG PRODUCTS SERVICES in Europe
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Austria Europe
FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC BIOLOGICS COSMETICS NUTRACEUTICALS SERVICES OLIGONUCLEOTIDES in Europe Discover our facility

A high-performance production facility that complies with the latest GMP standards for sterile and aseptic liquids, particularly glass ampoules.

  • Activity: CHEMICAL-SYNTHETIC, BIOLOGICS, OLIGONUCLEOTIDES,... manufacturing
  • Uses: Investigational, Commercial (Phase IV)
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
  • Services: N/A
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1
  • Markets: EMA (EU), PMDA (Japan), MHRA (UK), MFDS (South...
FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC BIOLOGICS COSMETICS NUTRACEUTICALS SERVICES OLIGONUCLEOTIDES in Europe
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France Europe
FDF / DRUG PRODUCTS SERVICES in Europe Discover our facility

Make affordable healthcare solutions that improve and simplify patients lives

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Batch certification / release, Primary packaging,...
  • Batch Size / Reactor: Medium, Large
  • Controlled substance: High potential for abuse & medical use
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
i+Med | Drug products, Cosmetics, Nutraceutics & Medical Devices
Spain Europe
i+Med | Drug products, Cosmetics, Nutraceutics & Medical Devices Discover our facility

Developer and manufacturer of new drug products with control realease technologies.

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (D)...
  • Certifications: ISO
  • Services: Batch certification / release, Primary packaging,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2, 3, 4
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
FDF / DRUG PRODUCTS COSMETICS NUTRACEUTICALS in Europe
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Belgium Europe
FDF / DRUG PRODUCTS in Europe Discover our facility

This 8,000 m2 plant, with buildings dotted around a site of nearly seven hectares, is located 20 km south of Brussels and has 340 employees*. It specializes in the production of sterile highly potent injectables, mainly against cancer.

  • Activity: Injectables, FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (G) Genito urinary system and sex hormones, (H)...
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: High potential for abuse & medical use, Lower...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2, 3, 4
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
FDF / DRUG PRODUCTS in Europe
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Spain Europe
FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC SERVICES in Europe Discover our facility

Solutions for non Viral Delivery programs

  • Activity: Injectables, CHEMICAL-SYNTHETIC, Sterile forms... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: CMC regulatory support, R&D, Tech transfer, IND...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2, 3
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC SERVICES in Europe
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India APAC
CHEMICAL-SYNTHETIC PARTICLE ENGINEERING in APAC Discover our facility

An API and Interemediate manufacturer having global certifications.

  • Activity: CHEMICAL-SYNTHETIC, PARTICLE ENGINEERING manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (C) Cardiovascular system, (G) Genito urinary...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: Primary packaging, Storage, Tech transfer,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 -...
  • BSL: 3, 4
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), TGA...
CHEMICAL-SYNTHETIC PARTICLE ENGINEERING in APAC
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United States North America
FDF / DRUG PRODUCTS in North America Discover our facility

CDMO that manufactures clinical & commercial sterile injectable drug products.

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2, 3
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
CARBOGEN AMCIS | Bubendorf
Switzerland Europe
CARBOGEN AMCIS | Bubendorf Discover our facility

Development and cGMPmanufacturing of Highly Potent API including Antibody Drug Conjugates (ADC)

  • Activity: CHEMICAL-SYNTHETIC, BIOLOGICS, ADC & NDC... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: Batch certification / release, CMC regulatory...
  • Batch Size / Reactor: Small, Medium
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
CHEMICAL-SYNTHETIC BIOLOGICS SERVICES in Europe
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India APAC
FDF / DRUG PRODUCTS NUTRACEUTICALS in APAC Discover our facility

Manufacturer and Exporter of fiished formulations

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS,... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), Health Canada (Canada GMP), TGA...
  • Services: R&D, Formulation / Galenic design, QbD (Quality by...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: EMA (EU), MHRA (UK), Health Canada (Canada), TGA...
CARBOGEN AMCIS | Shanghai, China
China APAC
CARBOGEN AMCIS | Shanghai, China Discover our facility

Large scale manufacturing.

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: NMPA (China GMP), ANVISA (Brazil B-GMP)
  • Services: Batch certification / release, Primary packaging,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Adare Pharma | US
United States North America
Adare Pharma | US Discover our facility

Adare Pharma is a global CDMO with sites in US and EU providing turnkey product development through commercial manufacturing expertise focused on oral dosage forms for the Pharmaceutical, Animal Health and OTC markets. Adare s proprietary technology platforms specialize in ODT s, taste masking and customized drug release.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS, SERVICES manufacturing
  • Uses: N/A
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Pharmaron API Commercial Synthesis Cramlington (UK)
United Kingdom Europe
Pharmaron API Commercial Synthesis Cramlington (UK) Discover our facility

Commercial API Small Molecules Synthesis

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Batch certification / release, CMC regulatory...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
CHEMICAL-SYNTHETIC in Europe
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India APAC
FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC in APAC Discover our facility

Synfine Drugs

  • Activity: CHEMICAL-SYNTHETIC, FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Commercial (Phase IV)
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: N/A
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: Lower potential for abuse, Low potential for...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
FAES FARMA | DERIO facility
Spain Europe
FAES FARMA | DERIO facility Discover our facility

Developer and manufacturer of human medicinal products.

  • Activity: Sterile forms (ophtalmic, nasal, otic), Oral... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Batch certification / release, Primary packaging,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
FDF / DRUG PRODUCTS in Europe
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Italy Europe
CHEMICAL-SYNTHETIC SERVICES in Europe Discover our facility

European CDMO Specialized in Steroids, Hormones & HPAPI

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (C) Cardiovascular system, (D) Dermatologicals,...
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Batch certification / release, R&D, Tech transfer,...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: High potential for abuse & medical use, Lower...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2, 3, 4
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Adare Pharma | EU
Italy Europe
Adare Pharma | EU Discover our facility

Adare Pharma is a global CDMO with sites in US and EU providing turnkey product development through commercial manufacturing expertise focused on oral dosage forms for the Pharmaceutical, Animal Health and OTC markets. Adare s proprietary technology platforms specialize in ODT s, taste masking and customized drug release.

  • Activity: Oral solids / OSD, PARTICLE ENGINEERING, FDF /... manufacturing
  • Uses: N/A
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Shilpa Biologicals Private Limited
India APAC
Shilpa Biologicals Private Limited Discover our facility

Shilpa Biologicals is a CDMO which support Process Development, Gene to Cell Line Development to GMP to Formulation Development, Analytical Development, Process Development, Drug Substance, Drug Product, Fill-Finish and Packaging

  • Activity: Abs (Antibodies), BIOLOGICS, ADC & NDC... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO
  • Services: Upstream, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Medium, Fed-batch, 100 -...
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2, 3
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
CARBOGEN AMCIS | Saint-Beauzire
France Europe
CARBOGEN AMCIS | Saint-Beauzire Discover our facility

Custom formulation development and GMP sterile manufacture of liquid and lyophilized drug product

  • Activity: FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Commercial (Phase IV)
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: N/A
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
FDF / DRUG PRODUCTS in Europe
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India APAC
FDF / DRUG PRODUCTS SERVICES in APAC Discover our facility

Block A, established in 1999, houses production lines for a diverse array of sterile products including Ophthalmic Drops, Pre-filled Syringes, Sterile Eye Ointments, Ampoules, and Inhaled AnesthesiaBlock B, constructed in 2019, features lines for Liquid Vials and Lyophilization, Liquid Ampoules, and Sterile Dry Powder filling.Block C, also built in 2019, serves as the hub for our Quality Assurance, Quality Control, and Administration departments.

  • Activity: Injectables, FDF / DRUG PRODUCTS, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: Lower potential for abuse, Low potential for...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: EMA (EU), MHRA (UK), Health Canada (Canada), TGA...
MENADIONA S.L
Spain Europe
MENADIONA S.L Discover our facility

Contract development and manufacturing partner located in Spain for APIs, Intermediates and fine chemicals specialized in transferring R&D projects into fully cGMP-compliant manufacturing processes.

  • Activity: CHEMICAL-SYNTHETIC, COSMETICS, NUTRACEUTICALS,... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), ECOVADIS, World...
  • Services: Batch certification / release, Primary packaging,...
  • Batch Size / Reactor: Medium, Large
  • Controlled substance: Low potential for abuse, Lowest potential for...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
CARBOGEN AMCIS | Veenendaal
Netherlands Europe
CARBOGEN AMCIS | Veenendaal Discover our facility

Large scale manufacturing of Cholesterol and Vitamin D analogs.

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Batch certification / release, Primary packaging,...
  • Batch Size / Reactor: Small
  • Controlled substance: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
CHEMICAL-SYNTHETIC SERVICES in Europe
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China APAC
FDF / DRUG PRODUCTS SERVICES in APAC Discover our facility

As one of three core facilities, alongside the R&D Center and API Manufacturing Site, the Formulation Manufacturing Site is dedicated to the development and production of complex and high-value dosage forms.

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2, 3, 4
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
FDF / DRUG PRODUCTS SERVICES in APAC
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China APAC
CHEMICAL-SYNTHETIC in APAC Discover our facility

As one of three core sites, alongside the R&D center and formulation plant, our API manufacturing facility plays a vital role in the integrated supply chain.

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2, 3, 4
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
CHEMICAL-SYNTHETIC in APAC
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China APAC
FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC in APAC Discover our facility

As one of the three core facilities, alongside the API Manufacturing Site and Formulation Manufacturing Site, the R&D Center plays a pivotal role in supporting the development of both APIs and finished dosage forms. It focuses on early-stage research, process development, analytical support, and scale-up studies to ensure efficient transfer from lab to commercial manufacturing.

  • Activity: Injectables, CHEMICAL-SYNTHETIC, Sterile forms... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • Controlled substance: High potential for abuse & no medical use, High...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2, 3, 4
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...

Japan has established itself as one of the world’s most respected pharmaceutical markets, renowned for its precision, quality culture, and technological excellence. In the field of contract development and manufacturing organizations (CDMOs), Japan stands out for its advanced manufacturing capabilities, strict regulatory standards, and highly experienced workforce. Partnering with CDMOs in Japan ensures access to reliable, high-quality pharmaceutical development and manufacturing services trusted across global markets.

Whether you are a biotech startup or an established pharmaceutical company seeking to outsource development, formulation, or production, Japanese CDMOs offer a strategic advantage for bringing drug products to market efficiently, safely, and in full regulatory compliance.

Why Choose CDMO Companies in Japan?

Japan combines a long pharmaceutical heritage with a deeply embedded commitment to quality and continuous improvement. Here’s why companies worldwide choose to work with CDMOs in Japan:

  • Regulatory Excellence: Japanese CDMOs operate in full compliance with PMDA regulations and are closely aligned with EMA and FDA requirements, ensuring smooth global market access.
  • Precision Manufacturing: Japan is globally recognized for its manufacturing accuracy, process control, and robust quality management systems.
  • Advanced Technologies: Strong capabilities in automation, continuous manufacturing, data integrity, and advanced analytical systems.
  • Highly Skilled Workforce: Japanese CDMOs benefit from a workforce of experienced scientists, engineers, and quality professionals with deep expertise in regulated environments.

Key Services Offered by Japanese Contract Manufacturers

CDMOs in Japan provide a comprehensive range of end-to-end pharmaceutical services, including:

  • Drug Development: Pre-formulation, analytical development, formulation design, and process optimization
  • Clinical Manufacturing: GMP-compliant production of clinical trial materials
  • Commercial Manufacturing: Scalable production for domestic and international markets, including packaging and labeling
  • Sterile & Aseptic Manufacturing: Injectable drug products, vials, ampoules, and other sterile dosage forms
  • API Manufacturing: Small-molecule APIs and advanced intermediates under GMP conditions
  • Quality Assurance & Regulatory Support: PMDA submissions, global filings, audits, and lifecycle management

Japanese CDMOs are particularly valued for projects requiring high precision, robust quality systems, and long-term manufacturing reliability.

Advantages of Partnering with CDMOs in Japan

Choosing a Japanese CDMO offers multiple strategic and operational advantages:

  • Uncompromising Quality: Quality is a core principle in Japanese pharmaceutical manufacturing, not just a regulatory requirement.
  • Operational Reliability: Strong project governance, risk management, and supply continuity.
  • Technological Leadership: Continuous investment in advanced manufacturing and digitalization.
  • Global Regulatory Acceptance: Products manufactured in Japan are widely trusted by international regulatory authorities.

CDMO Companies in Japan

Some of the leading CDMOs in Japan include:

Adragos Pharma: CDMO in Japan providing pharmaceutical development and GMP manufacturing services. [See CDMO profile]

Related Information

Let MAI CDMO Network Help You Find the Right Japanese Partner

At MAI CDMO, we connect pharmaceutical and biotech companies with the most suitable CDMOs in Japan. Whether you require support for drug development, contract manufacturing, API production, or sterile manufacturing, we simplify the process of identifying, qualifying, and engaging with the right Japanese CDMO to meet your project objectives.

Ready to explore your options? Contact us today and let us help you find a Japanese partner that meets your quality standards, timelines, and long-term growth goals.

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ADRAGOS PHARMA
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