Softgel Capsules CDMO | Softgel Capsules Contract Manufacturing

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

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

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

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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)

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)

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)

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)

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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

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

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)

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: Storage, R&D, CMC regulatory support, Tech...

Batch Size / Reactor: Small, Medium, Large
Controlled substance: N/A
Toxicity (OEB classification): N/A
BSL: N/A
Markets: EMA (EU)

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)

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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: R&D, Batch certification / release, CMC regulatory...

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

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: R&D, Tech transfer, Analytical methods...

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)

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: R&D, Tech transfer, Analytical methods...

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)

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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: Tech transfer, Batch certification / release,...

Batch Size / Reactor: Small, Medium
Controlled substance: N/A
Toxicity (OEB classification): N/A
BSL: N/A
Markets: FDA (USA), EMA (EU), MHRA (UK)

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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

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

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)

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...

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: 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), 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: R&D, Analytical methods development, Batch...

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),...

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: 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)

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: R&D, Tech transfer, Analytical methods...

Batch Size / Reactor: Small, Medium, Large
Controlled substance: N/A
Toxicity (OEB classification): N/A
BSL: N/A
Markets: FDA (USA), EMA (EU)

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),...

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: 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)
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: Batch certification / release, R&D, Primary...

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)

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)

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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: R&D, Primary packaging, CMC regulatory support,...

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)

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: CMC regulatory support, R&D, Upstream, Tech...

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: R&D, Batch certification / release, Primary...

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)

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: 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: 1
Markets: FDA (USA), EMA (EU), MHRA (UK), Health Canada...

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: R&D, Tech transfer, Primary packaging, Storage,...

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...

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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: R&D, Batch certification / release, Primary...

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)

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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: 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: 1
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...

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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: 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), 2 (PDE =...
BSL: N/A
Markets: FDA (USA), EMA (EU), MHRA (UK), TGA (Australia)

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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: Upstream, Tech transfer, Analytical methods...

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)

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...

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)

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)

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: Tech transfer, Batch certification / release,...

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),...

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),...

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: 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),...

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...

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: R&D, Tech transfer, Analytical methods...

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),...

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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: Storage, R&D, CMC regulatory support, Tech...

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),...

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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...

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: R&D, Tech transfer, Analytical methods...

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),...

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

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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...

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),...

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...

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...

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: Storage, R&D, CMC regulatory support, Tech...

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),...

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),...

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...

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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

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),...

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: R&D, Tech transfer, Analytical methods...

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),...

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: R&D, Batch certification / release, Primary...

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),...

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: R&D, Tech transfer, 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), MHRA (UK),...

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: R&D, Tech transfer, Batch certification / release,...

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)

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: R&D, Tech transfer, Analytical methods...

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),...

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),...

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: R&D, Tech transfer, Analytical methods...

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),...

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: R&D, Tech transfer, Analytical methods...

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),...

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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)

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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

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: R&D, Tech transfer, Analytical methods...

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),...

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: R&D, Tech transfer, Analytical methods...

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: CMC regulatory support, R&D, Tech transfer,...

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),...

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: Storage, CMC regulatory support, 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, 2
Markets: FDA (USA), EMA (EU), MHRA (UK), Health Canada...

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: R&D, Batch certification / release, Primary...

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),...

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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: CMC regulatory support, 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),...

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...

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: R&D, Tech transfer, Analytical methods...

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),...

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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),...

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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: Batch certification / release, CMC regulatory...

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),...

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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: 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): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
BSL: 1, 2
Markets: FDA (USA), EMA (EU)

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: R&D, Tech transfer, Analytical methods...

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...

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: 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: 1, 2
Markets: FDA (USA), EMA (EU), Turkish Health Authorities,...

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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: CMC regulatory support, R&D, Tech transfer,...

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)

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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: R&D, Batch certification / release, Primary...

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),...

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: R&D, Tech transfer, Analytical methods...

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),...

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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: R&D, CMC regulatory support, Tech transfer,...

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...

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)

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: R&D, Tech transfer, Analytical methods...

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),...

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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),...

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...

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...

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: 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), NMPA (China)

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: CMC regulatory support, Tech transfer, Analytical...

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...

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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: Storage, CMC regulatory support, R&D, Tech...

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),...

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: R&D, Tech transfer, Analytical methods...

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),...

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: R&D, Batch certification / release, Upstream, Tech...

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: R&D, Storage, CMC regulatory support, Tech...

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)

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: R&D, Tech transfer, Analytical methods...

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)

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...

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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: 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), MHRA (UK), MFDS...

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...

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: R&D, Batch certification / release, Upstream, Tech...

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),...

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),...

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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: 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), 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: 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), MHRA (UK), MFDS...

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: R&D, Batch certification / release, Primary...

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),...

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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: R&D, Storage, CMC regulatory support, Tech...

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),...

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: Tech transfer, Analytical methods development,...

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),...

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: Storage, R&D, CMC regulatory support, Tech...

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),...

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: Primary packaging, R&D, CMC regulatory support,...

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...

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: Storage, R&D, CMC regulatory support, Tech...

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),...

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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: 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: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...

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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: Storage, R&D, CMC regulatory support, Tech...

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),...

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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: R&D, Tech transfer, Analytical methods...

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),...

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: 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: 1, 2, 3, 4
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...

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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: Primary packaging, R&D, Storage, CMC regulatory...

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),...

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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: R&D, Tech transfer, CMC regulatory support,...

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: Tech transfer, Analytical methods development,...

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: R&D, CMC regulatory support, 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, 3
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...

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: R&D, Tech transfer, Analytical methods...

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...

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: R&D, CMC regulatory support, 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: N/A
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...

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: R&D, Storage, CMC regulatory support, 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), NMPA (China),...

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: R&D, Tech transfer, Analytical methods...

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),...

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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),...

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: CMC regulatory support, R&D, Tech transfer, Batch...

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),...

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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: R&D, Tech transfer, 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: 1, 2, 3, 4
Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...

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: R&D, Storage, CMC regulatory support, 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), NMPA (China),...

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: Analytical methods development, R&D, Batch...

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),...

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),...

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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: Batch certification / release, R&D, Primary...

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...

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: R&D, Tech transfer, Analytical methods...

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),...

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: CMC regulatory support, R&D, Tech transfer,...

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),...

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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: Batch certification / release, R&D, Primary...

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),...

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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: Batch certification / release, R&D, Primary...

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),...

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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: Batch certification / release, R&D, Primary...

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),...

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