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EMA EU GMP CDMO Companies | European Pharmaceutical Manufacturing Services

Your Trusted Partners for European Pharmaceutical Manufacturing and Development

  
Aenova Group
Germany Europe
Aenova Group Discover our facility

Headquarter - Location Starnberg

  • Activity: N/A manufacturing
  • Uses: N/A
  • Therapeutic areas: N/A
  • Certifications: N/A
  • Services: N/A
  • Batch Size / Reactor: N/A
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: N/A
in Europe
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United States North America
in North America Discover our facility

GMP-certified protein production as a U.S.-based CDMO, supporting both academic research institutions and biotechnology/pharmaceutical companies.

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

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

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

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

  • Activity: SERVICES manufacturing
  • Uses: N/A
  • Therapeutic areas: N/A
  • Certifications: N/A
  • Services: Storage, Stability studies design, Stability...
  • Batch Size / Reactor: N/A
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: N/A
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: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO
  • Services: N/A
  • Batch Size / Reactor: Small, Medium
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: N/A
Rodon Biologics
Portugal Europe
Rodon Biologics Discover our facility

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

  • Activity: BIOLOGICS, Abs (Antibodies), Peptide, protein,... manufacturing
  • Uses: Investigational
  • Therapeutic areas: N/A
  • Certifications: N/A
  • Services: Upstream, Downstream, Cell line development,...
  • Batch Size / Reactor: Batch, 1 - 100 L, Small, Fed-batch
  • DEA: 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
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: EMA (EU)
White Raven - Legiapark
Belgium Europe
White Raven - Legiapark Discover our facility

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

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

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

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

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

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

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

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

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

  • Activity: Injectables, FDF / DRUG PRODUCTS manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP)
  • Services: R&D, CMC regulatory support, Tech transfer,...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: EMA (EU)
Aenova Group - Location Greensboro, USA
United States North America
Aenova Group - Location Greensboro, USA Discover our facility

Competence Center Packaging Solids.

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

Oligonucleotide manufacturer

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

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

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Preclinical, Investigational, Phase I, Phase II
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP)
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2
  • Markets: EMA (EU)
Green Phoenix Labs GmbH
Germany Europe
Green Phoenix Labs GmbH Discover our facility

Cell Therapy company with excess Cleanroom capacity

  • Activity: Cell therapy, ATMP (Advanced Therapies),... manufacturing
  • Uses: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: (G) Genito urinary system and sex hormones
  • Certifications: EMA (EU GMP)
  • Services: Tech transfer, Primary packaging, Pilot plant,...
  • Batch Size / Reactor: Small, Medium
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: EMA (EU)
VIVEbiotech
Spain Europe
VIVEbiotech Discover our facility

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

  • Activity: ATMP (Advanced Therapies), BIOLOGICS, GTMP (Gene... manufacturing
  • Uses: Preclinical, Investigational, 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: 1 - 100 L, Small, Medium, 100 - 1000 L, Large,...
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2
  • Markets: N/A
VIVUNT PHARMA
Spain Europe
VIVUNT PHARMA Discover our facility

CDMO Sterile Oncology Drugs

  • Activity: Injectables, FDF / DRUG PRODUCTS manufacturing
  • Uses: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: (L) Antineoplastic and immunomodulating agents
  • Certifications: EMA (EU GMP)
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: EMA (EU)
Ophtapharm, a Sentiss Company
Switzerland Europe
Ophtapharm, a Sentiss Company Discover our facility

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

  • Activity: Sterile forms (ophtalmic, nasal, otic), FDF / DRUG... manufacturing
  • Uses: Preclinical, Investigational, 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
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU)
TRADICHEM INDUSTRIAL SERVICES
Spain Europe
TRADICHEM INDUSTRIAL SERVICES Discover our facility

HIPERING® TECHNOLOGY - THE GATEWAY FOR LEAN MANUFACTURING

  • Activity: API PROCESSING manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: R&D, Pilot plant, Preformulation studies,...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU)
PHARMALOOP S.L. - a Salvat Company
Spain Europe
PHARMALOOP S.L. - a Salvat Company Discover our facility

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

  • Activity: Sterile forms (ophtalmic, nasal, otic), Oral... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (S) Sensory organs, (V01) Allergens
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP)
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
  • BSL: 1
  • Markets: FDA (USA), EMA (EU)
Rioja Nature Pharma
Spain Europe
Rioja Nature Pharma Discover our facility

CDMO NUTRACEUTICALS/FOOD SUPPLEMENTS

  • Activity: NUTRACEUTICALS manufacturing
  • Uses: N/A
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), World Health...
  • Services: N/A
  • Batch Size / Reactor: Medium
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), NMPA (China), MHRA (UK),...
BAG Health Care
Germany Europe
BAG Health Care Discover our facility

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

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

mRNA & LNP manufacturing, F&F

  • Activity: ATMP (Advanced Therapies), Injectables, BIOLOGICS,... manufacturing
  • Uses: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP)
  • Services: R&D, Primary packaging, CMC regulatory support,...
  • Batch Size / Reactor: Batch, 1 - 100 L, Small, Medium, 100 - 1000 L,...
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
  • BSL: 1
  • Markets: FDA (USA), EMA (EU), PMDA (Japan)
Cellex Cell Professionals
Germany Europe
Cellex Cell Professionals Discover our facility

CGT CDMO Cell Manufacturing Plant and Collection Center for Starting Materials

  • Activity: ATMP (Advanced Therapies), Cell therapy, GTMP... manufacturing
  • Uses: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP)
  • Services: Upstream, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: 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, Fed-batch, 100 - 1000 L, Medium,...
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2
  • Markets: EMA (EU)
BDI biotech Production Plant
Spain Europe
BDI biotech Production Plant Discover our facility

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

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

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

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS manufacturing
  • Uses: Preclinical, Investigational, 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
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), MFDS (South Korea), ANVISA...
FDF / DRUG PRODUCTS in Europe
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Spain Europe
FDF / DRUG PRODUCTS BIOLOGICS in Europe Discover our facility

Clinical Trials Facility

  • Activity: ATMP (Advanced Therapies), Injectables, Cell... manufacturing
  • Uses: Preclinical, Investigational, 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: Batch, 1 - 100 L, Small
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 2
  • Markets: EMA (EU), CDSCO (India), ANVISA (Brazil)
Basic Pharma Manufacturing
Netherlands Europe
Basic Pharma Manufacturing Discover our facility

Basic Pharma can bring 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: Preclinical, Investigational, 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
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), MHRA (UK), TGA (Australia)
FDF / DRUG PRODUCTS in Europe
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Spain Europe
FDF / DRUG PRODUCTS BIOLOGICS in Europe Discover our facility

Single Use Commercial Scale Facility

  • Activity: Injectables, BIOLOGICS, Abs (Antibodies), 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, Fed-batch, 100 - 1000 L, Medium,...
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2
  • Markets: EMA (EU)
Viswa Laboratories Pvt Ltd
India APAC
Viswa Laboratories Pvt Ltd Discover our facility

CRAMS/CDMO, APIs, Intermediates and specialty chemicals

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Preclinical, Investigational, 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
  • DEA: Schedule III (lower potential for abuse)
  • Toxicity (OEB classification): 3 (PDE = 100 - 1,000 µg/day)
  • BSL: 2
  • Markets: EMA (EU), NMPA (China), CDSCO (India), ANVISA...
Aenova Group - Location Bad Aibling, Germany
Germany Europe
Aenova Group - Location Bad Aibling, Germany Discover our facility

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

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

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

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

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

  • Activity: FDF / DRUG PRODUCTS manufacturing
  • Uses: Preclinical, Investigational, 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
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1
  • Markets: FDA (USA), EMA (EU), MHRA (UK), ANVISA (Brazil),...
Aenova Group - Location Carugate, Italy
Italy Europe
Aenova Group - Location Carugate, Italy Discover our facility

Competence Center Semisolids and non-sterile liquids.

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

Competence Center complex conventional solids and narcotics.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS,... manufacturing
  • Uses: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: Primary packaging, Tech transfer, Secondary...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: 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...
Kemwell Biopharma Pvt Ltd
India APAC
Kemwell Biopharma Pvt Ltd Discover our facility

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

  • Activity: BIOLOGICS, Abs (Antibodies), Peptide, protein,... manufacturing
  • Uses: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: FDA (cGMP)
  • Services: R&D, Batch certification / release, Primary...
  • Batch Size / Reactor: 1 - 100 L, Small, Medium, Fed-batch, 100 - 1000 L,...
  • DEA: 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), CDSCO (India)
Adragos Pharma | Leipzig
Germany Europe
Adragos Pharma | Leipzig 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
  • DEA: Schedule II (high potential for abuse / medical...
  • 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),...
FDF / DRUG PRODUCTS in Europe
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Italy Europe
FDF / DRUG PRODUCTS in Europe Discover our facility

Oral forms (liquid & solid)

  • Activity: Oral solids / OSD, Oral liquids and semisolids,... manufacturing
  • Uses: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), World Health Organization (GMP...
  • Services: R&D, Tech transfer, Pilot plant, Preformulation...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: Schedule I (high potential for abuse / no medical...
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: EMA (EU), MHRA (UK), MFDS (South Korea), Russian...
Content Group | Pomezia Plant
Italy Europe
Content Group | Pomezia Plant Discover our facility

Tubilux Pharma: registered office; manufacturing facility

  • Activity: Sterile forms (ophtalmic, nasal, otic), FDF / DRUG... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (S) Sensory organs
  • Certifications: EMA (EU GMP), FDA (cGMP), TGA (Australia GMP),...
  • Services: R&D, Tech transfer, Batch certification / release,...
  • Batch Size / Reactor: Medium, Large
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), TGA (Australia), ANVISA...
Aenova Group - Location Killorglin, Ireland
Ireland Europe
Aenova Group - Location Killorglin, Ireland Discover our facility

Competence Center for spray drying and modified release pellets.

  • Activity: Oral solids / OSD, API PROCESSING, FDF / DRUG... 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
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: EMA (EU), PMDA (Japan), MFDS (South Korea), SFDA...
Cambrex Waltham (Snapdragon Chemistry)
United States North America
Cambrex Waltham (Snapdragon Chemistry) Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Preclinical, Investigational, 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
  • DEA: 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),...
Adragos Pharma | Jura
Switzerland Europe
Adragos Pharma | Jura 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: Preclinical, Investigational, 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
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
FDF / DRUG PRODUCTS BIOLOGICS in Europe
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Canada North America
FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC SERVICES in North America Discover our facility

Pharma CRO/CMO

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

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

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

Competence Center Semisolids and Liquids.

  • Activity: Oral liquids and semisolids, FDF / DRUG PRODUCTS,... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (D) Dermatologicals, (J) Antiinfectives for...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Roszdravnadzor...
  • Services: Tech transfer, Primary packaging, R&D, Secondary...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: 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
Cultiply
Spain Europe
Cultiply Discover our facility

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

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

Competence Center complex conventional solids.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS,... manufacturing
  • Uses: Preclinical, Investigational, 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
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), MFDS (South Korea), Turkish Health...
Aenova Group - Location Tittmoning, Germany
Germany Europe
Aenova Group - Location Tittmoning, Germany Discover our facility

Competence Center conventional solids high volume plant.

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

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

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

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Preclinical, Investigational, 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
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Sidefarma
Portugal Europe
Sidefarma Discover our facility

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

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

R&D Centre

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: Preclinical, Investigational
  • 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
  • DEA: Schedule I (high potential for abuse / no medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: N/A
Aenova Group - Location Gronau, Germany
Germany Europe
Aenova Group - Location Gronau, Germany Discover our facility

Competence center for conventional solids and clinical services.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS manufacturing
  • Uses: Preclinical, Investigational, 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
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), EDE (UAE),...
CARBOGEN AMCIS | Aarau
Switzerland Europe
CARBOGEN AMCIS | Aarau Discover our facility

Development and medium scale cGMP manufacturing including chromatography

  • Activity: CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES manufacturing
  • Uses: Preclinical, Investigational, 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
  • DEA: 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),...
AdhexPharma SAS
France Europe
AdhexPharma SAS Discover our facility

CDMO for transdermal patches and oromucosal films

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS, Topical,... manufacturing
  • Uses: Preclinical, Investigational, 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
  • DEA: Schedule II (high potential for abuse / medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
Cambrex Durham
United States North America
Cambrex Durham Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: Preclinical, Investigational, Phase I, Phase II
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small
  • DEA: Schedule II (high potential for abuse / medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
Cambrex Edinburgh
United Kingdom Europe
Cambrex Edinburgh Discover our facility

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

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

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

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

Development and medium scale manufacturing

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: Preclinical, Investigational, 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
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
CHEMICAL-SYNTHETIC SERVICES in Europe
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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: Preclinical, Investigational, 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
  • DEA: Schedule I (high potential for abuse / no medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: N/A
Cambrex Karlskoga
Sweden Europe
Cambrex Karlskoga Discover our facility

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

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

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

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

Boronia, VIC, Australia

  • Activity: Injectables, Oral solids / OSD, API PROCESSING,... manufacturing
  • Uses: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: (C) Cardiovascular system, (L) Antineoplastic and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), Health Canada...
Glatt Pharmaceutical Services GmbH Co. & KG
Germany Europe
Glatt Pharmaceutical Services GmbH Co. & KG Discover our facility

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

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Commercial (Phase IV), Phase I,...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: EMA (EU GMP), FDA (cGMP)
  • Services: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1
  • Markets: FDA (USA), EMA (EU)
Adragos Pharma | Livron
France Europe
Adragos Pharma | Livron 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: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: Schedule I (high potential for abuse / no medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK),...
53Biologics Production Plant
Spain Europe
53Biologics Production Plant Discover our facility

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

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

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

  • Activity: BIOLOGICS, Abs (Antibodies), ADC & NDC... manufacturing
  • Uses: Preclinical, Investigational, 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: Batch, 1 - 100 L, Small, Medium, 100 - 1000 L,...
  • DEA: Schedule V (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),...
Cenexi SAS
France Europe
Cenexi SAS 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: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: (G) Genito urinary system and sex hormones, (H)...
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Aenova Group - Location Münster, Germany
Germany Europe
Aenova Group - Location Münster, Germany Discover our facility

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

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS, Inhalation... manufacturing
  • Uses: Preclinical, Investigational, 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
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), MFDS (South Korea), Turkish...
Cambrex High Point
United States North America
Cambrex High Point Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Commercial (Phase IV), Phase I,...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium
  • DEA: Schedule I (high potential for abuse / no medical...
  • 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),...
Adragos Pharma | Kawagoe
Japan APAC
Adragos Pharma | Kawagoe 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
  • DEA: Schedule II (high potential for abuse / medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
FDF / DRUG PRODUCTS SERVICES in APAC
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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: BIOLOGICS, Abs (Antibodies), Peptide, protein,... manufacturing
  • Uses: Preclinical, Investigational, 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: Batch, 1 - 100 L, Small, Medium, Fed-batch, 100 -...
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU)
Actylis Eugene
United States North America
Actylis Eugene Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Preclinical, Investigational, 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
  • DEA: Schedule III (lower potential for abuse), Schedule...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), MHRA (UK), Health Canada...
Aenova Group - Location Latina, Italy
Italy Europe
Aenova Group - Location Latina, Italy Discover our facility

Competence Center animal health products and sterile technologies.

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Preclinical, Investigational, 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
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU), Turkish Health Authorities,...
FDF / DRUG PRODUCTS BIOLOGICS in Europe
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Lithuania Europe
FDF / DRUG PRODUCTS BIOLOGICS SERVICES API PROCESSING in Europe Discover our facility

Global End-to-End Biologics CDMO

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

Pagari

  • Activity: Oral solids / OSD, Oral liquids and semisolids,... manufacturing
  • Uses: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, FDA (cGMP), World Health Organization (GMP /...
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: N/A
  • Toxicity (OEB classification): 3 (PDE = 100 - 1,000 µg/day)
  • BSL: 1
  • Markets: FDA (USA)
Laboratorio REIG JOFRE, SA (TOLEDO PLANTS)
Spain Europe
Laboratorio REIG JOFRE, SA (TOLEDO PLANTS) Discover our facility

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

  • Activity: Injectables, Oral solids / OSD, Oral liquids and... manufacturing
  • Uses: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: (J) Antiinfectives for systemic use
  • Certifications: EMA (EU GMP), ECOVADIS, World Health Organization...
  • Services: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Medium, Large
  • DEA: Schedule V (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), ANVISA...
FDF / DRUG PRODUCTS in Europe
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China APAC
FDF / DRUG PRODUCTS BIOLOGICS in APAC Discover our facility

Integrated development and cGMP manufacturing site

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

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Preclinical, Investigational, 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
  • DEA: Schedule I (high potential for abuse / no medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
CHEMICAL-SYNTHETIC in North America
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United Kingdom Europe
FDF / DRUG PRODUCTS BIOLOGICS SERVICES OLIGONUCLEOTIDES in Europe Discover our facility

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

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Preclinical, Investigational, 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
  • DEA: Schedule I (high potential for abuse / no medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1
  • Markets: FDA (USA), EMA (EU), MHRA (UK), Health Canada...
ChemCon GmbH
Germany Europe
ChemCon GmbH Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (C) Cardiovascular system, (N) Nervous system, (R)...
  • Certifications: EMA (EU GMP), FDA (cGMP), ECOVADIS
  • Services: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small, Medium
  • DEA: Schedule II (high potential for abuse / medical...
  • 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),...
Cenexi Hérouville Saint Clair
France Europe
Cenexi Hérouville Saint Clair 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: Batch certification / release, Primary packaging,...
  • Batch Size / Reactor: Small, Medium
  • DEA: Schedule I (high potential for abuse / no medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Aenova Group - Location Regensburg, Germany
Germany Europe
Aenova Group - Location Regensburg, Germany Discover our facility

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

  • Activity: Oral solids / OSD, API PROCESSING, Oral liquids... manufacturing
  • Uses: Preclinical, Investigational, 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
  • DEA: 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...
Ascendia Pharmaceutical Solutions
United States North America
Ascendia Pharmaceutical Solutions Discover our facility

Your trusted GMP-certified CDMO for advanced sterile and non-sterile pharmaceutical manufacturing, formulation development, and analytical testing.

  • Activity: CHEMICAL-SYNTHETIC, BIOLOGICS, OLIGONUCLEOTIDES,... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: FDA (cGMP)
  • Services: N/A
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: Schedule II (high potential for abuse / medical...
  • Toxicity (OEB classification): 4 / HPAPI (PDE = 10 - 100 µg/day)
  • BSL: N/A
  • Markets: FDA (USA)
Darnytsia Kyiv
Ukraine Europe
Darnytsia Kyiv Discover our facility

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

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

Commercial API Small Molecules /Peptides Synthesis

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, FDA (cGMP), NMPA (China GMP)
  • Services: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), NMPA (China)
Cenexi SAS
France Europe
Cenexi SAS 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: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: Schedule I (high potential for abuse / no medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Apeloa Pharmaceutical Co., Ltd.
China APAC
Apeloa Pharmaceutical Co., Ltd. Discover our facility

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

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

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

  • Activity: ATMP (Advanced Therapies), Cell therapy,... manufacturing
  • Uses: Preclinical, Investigational, 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: 1 - 100 L, Small, Medium
  • DEA: 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: Preclinical, Investigational, 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
  • DEA: Schedule I (high potential for abuse / no medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2
  • Markets: FDA (USA)
Grifols International | Murcia Plant
Spain Europe
Grifols International | Murcia Plant Discover our facility

Sterile manufacturing solutions (small molecules) in flexible bags

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

One-stop CDMO Solutions for APl and Key intermediates.

  • Activity: ATMP (Advanced Therapies), Injectables,... manufacturing
  • Uses: Preclinical, Investigational, 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,...
  • DEA: Schedule III (lower potential for abuse), Schedule...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
  • BSL: 1, 2, 3, 4
  • Markets: NMPA (China)
Aenova Group - Location Kirchberg, Switzerland
Switzerland Europe
Aenova Group - Location Kirchberg, Switzerland Discover our facility

Competence Center Soft gelatin capsules.

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

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

  • Activity: BIOLOGICS, Abs (Antibodies), Peptide, protein,... manufacturing
  • Uses: Preclinical, Investigational, 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: Batch, 1 - 100 L, Small, Medium, Fed-batch, 100 -...
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
Pharmaron API Commercial Synthesis Coventry (US)
United States North America
Pharmaron API Commercial Synthesis Coventry (US) Discover our facility

Commercial API Small Molecules Synthesis

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, FDA (cGMP), ECOVADIS
  • Services: Tech transfer, Pilot plant, Scale-up, Research...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: Schedule I (high potential for abuse / no medical...
  • 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),...
HIPRA BIOTECH SERVICES | Amer
Spain Europe
HIPRA BIOTECH SERVICES | Amer Discover our facility

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

  • Activity: Injectables, BIOLOGICS, Abs (Antibodies), Peptide,... manufacturing
  • Uses: Preclinical, Investigational, 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: Batch, 1 - 100 L, Small, Medium, Fed-batch, 100 -...
  • DEA: 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),...
Adragos Pharma | Athens
Germany Europe
Adragos Pharma | Athens 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: Preclinical, Investigational, 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
  • DEA: Schedule II (high potential for abuse / medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Laboratorio REIG JOFRE, SA (BARCELONA PLANT)
Spain Europe
Laboratorio REIG JOFRE, SA (BARCELONA PLANT) Discover our facility

Injectable (lyo and liquid) and Liquid manufacturing facilities

  • Activity: Injectables, Oral liquids and semisolids, FDF /... manufacturing
  • Uses: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: EMA (EU GMP), Health Canada (Canada GMP),...
  • Services: R&D, CMC regulatory support, Tech transfer,...
  • Batch Size / Reactor: Medium, Large
  • DEA: Schedule III (lower potential for abuse), Schedule...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2, 3
  • Markets: EMA (EU), PMDA (Japan), MHRA (UK), TGA...
Lannett CDMO
United States North America
Lannett CDMO Discover our facility

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

  • Activity: Oral solids / OSD, Oral liquids and semisolids,... manufacturing
  • Uses: Investigational, Commercial (Phase IV), Phase II,...
  • Therapeutic areas: (C) Cardiovascular system, (H) Systemic hormonal...
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: R&D, CMC regulatory support, Tech transfer,...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: Schedule I (high potential for abuse / no medical...
  • 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),...
Grifols International | Barcelona Plant
Spain Europe
Grifols International | Barcelona Plant Discover our facility

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

  • Activity: Injectables, FDF / DRUG PRODUCTS manufacturing
  • Uses: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: R&D, CMC regulatory support, Tech transfer,...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: Schedule III (lower potential for abuse), Schedule...
  • 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),...
Adragos Pharma | Halden
Norway Europe
Adragos Pharma | Halden 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: Preclinical, Investigational, 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
  • DEA: Schedule II (high potential for abuse / medical...
  • 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),...
Lukas Heil-Betriebsstätte
Austria Europe
Lukas Heil-Betriebsstätte Discover our facility

LUKAS Heil-Betriebsstätte GmbH operates 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
  • DEA: Schedule I (high potential for abuse / no medical...
  • 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
  • DEA: Schedule II (high potential for abuse / medical...
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
i+Med | Drug products, Cosmetics, Nutraceutics & Medical Devices
Spain Europe
i+Med | Drug products, Cosmetics, Nutraceutics & Medical Devices Discover our facility

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

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Preclinical, Investigational, 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
  • DEA: 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),...
Cenexi Laboratoires Thissen
Belgium Europe
Cenexi Laboratoires Thissen 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: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: (G) Genito urinary system and sex hormones, (H)...
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: R&D, Storage, CMC regulatory support, Tech...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: Schedule II (high potential for abuse / medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2, 3, 4
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
FDF / DRUG PRODUCTS in Europe
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Spain Europe
FDF / DRUG PRODUCTS CHEMICAL-SYNTHETIC SERVICES in Europe Discover our facility

Solutions for non Viral Delivery programs

  • Activity: Injectables, CHEMICAL-SYNTHETIC, Sterile forms... manufacturing
  • Uses: Preclinical, Investigational, 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, Pilot...
  • Batch Size / Reactor: Small, Medium
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2, 3
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
CARBOGEN AMCIS | Bubendorf
Switzerland Europe
CARBOGEN AMCIS | Bubendorf Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC, BIOLOGICS, ADC & NDC... manufacturing
  • Uses: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small, Medium
  • DEA: 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),...
CARBOGEN AMCIS | Shanghai, China
China APAC
CARBOGEN AMCIS | Shanghai, China Discover our facility

Large scale manufacturing.

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: Preclinical, Investigational, 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
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
CHEMICAL-SYNTHETIC SERVICES in APAC
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United States North America
FDF / DRUG PRODUCTS SERVICES in North America 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
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Pharmaron API Commercial Synthesis Cramlington (UK)
United Kingdom Europe
Pharmaron API Commercial Synthesis Cramlington (UK) Discover our facility

Commercial API Small Molecules Synthesis

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

Synfine Drugs

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

Developer and manufacturer of human medicinal products.

  • Activity: Sterile forms (ophtalmic, nasal, otic), Oral... manufacturing
  • Uses: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: R&D, Tech transfer, Batch certification / release,...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: 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),...
Shilpa Biologicals Private Limited
India APAC
Shilpa Biologicals Private Limited Discover our facility

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

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

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

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

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

  • Activity: Injectables, FDF / DRUG PRODUCTS, SERVICES manufacturing
  • Uses: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: R&D, Primary packaging, Storage, CMC regulatory...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: Schedule III (lower potential for abuse), Schedule...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: EMA (EU), MHRA (UK), Health Canada (Canada), TGA...
MENADIONA S.L
Spain Europe
MENADIONA S.L Discover our facility

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

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

Large scale manufacturing of Cholesterol and Vitamin D analogs.

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

As one of Huiyu Pharmaceutical s three core facilities alongside our 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: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: R&D, Primary packaging, Storage, CMC regulatory...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: Schedule I (high potential for abuse / no medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2, 3, 4
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
FDF / DRUG PRODUCTS SERVICES in APAC
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China APAC
CHEMICAL-SYNTHETIC in APAC Discover our facility

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

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

As one of Huiyu Pharma s 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.

  • Activity: Injectables, CHEMICAL-SYNTHETIC, Sterile forms... manufacturing
  • Uses: Preclinical, Investigational, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: R&D, Primary packaging, Storage, CMC regulatory...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: Schedule I (high potential for abuse / no medical...
  • 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),...

To succeed in the European pharmaceutical market, companies must meet the rigorous quality and regulatory expectations set by the European Medicines Agency (EMA). That’s why pharma and biotech companies partner with experienced EMA EU GMP CDMO companies to ensure their products are developed and manufactured in full compliance with European pharmaceutical manufacturing standards.

With EMA-certified facilities, robust quality systems, and global submission support, these CDMOs help bring your product to EU and international markets safely and efficiently.

How to Choose EMA EU GMP CDMO Companies

When selecting EMA EU GMP CDMO companies, consider:

  • EU-GMP certification issued by national regulatory authorities in the EU

  • Successful EMA inspections and audit readiness for global compliance

  • Experience with both clinical and commercial-scale manufacturing

  • Proven quality systems in line with ICH Q7/Q8/Q10 standards

  • Support for EU submissions: MAA, CEP, IMPD, and ASMF documentation

  • Pharmacovigilance and Qualified Person (QP) release capabilities

  • Facility location within the European Economic Area (EEA)

The right CDMO ensures your project meets both technical and regulatory requirements for entry into the European market.

Key Services Offered by European Pharmaceutical Manufacturing Partners

Top-tier European pharmaceutical manufacturing providers typically offer:

  • GMP formulation development and process optimization

  • Manufacturing of oral solids, liquids, injectables, biologics, and APIs

  • Analytical testing and EU-compliant documentation

  • Sterile and non-sterile fill-finish capabilities

  • Batch certification and QP release for clinical and commercial supply

  • Support for EU submissions including IMPDs and CTAs

  • Technology transfer, scale-up, and process validation

  • Packaging and serialization according to EU FMD regulations

These services ensure full regulatory alignment and market readiness for EU and global supply.

Advantages of Partnering with EMA EU GMP CDMO Companies

Collaborating with experienced EMA EU GMP CDMO companies offers major advantages:

  • EU market access via compliant manufacturing and QP certification

  • Global regulatory acceptance with high EMA quality standards

  • Reduced risk of delays or rejections due to audit-proven processes

  • Support for complex drug formats and emerging therapies

  • Seamless integration of development, manufacturing, and submission workflows

European manufacturing quality is globally recognized — and your CDMO partner should reflect that.

EMA EU GMP CDMO Companies

Some of the most trusted EMA EU GMP CDMO companies include:

  • CDM Lavoisier: Human drugs CDMO specialized in the manufacturing of glass ampoules, glass vials and plastic (BFS) ampoules. [See CDMO profile]

  • Cenexi: CDMO that specializes in the production of sterile highly potent injectables, mainly against cancer. [See CDMO profile]

  • FAES FARMA: Developer and manufacturer of human medicinal products. [See CDMO profile]

  • ASCIL Biopharm: GMP facility fully equipped for R&D and pharmaceutical development. [See CDMO profile]

  • Grifols: Sterile manufacturing solutions (small molecules) in flexible bags and vials. [See CDMO profile]

  • VIVUNT PHARMA: CDMO for sterile oncology drugs. [See CDMO profile]

  • Liof Pharma: Reliable CDMO partner for aseptic manufacturing and lyophilization of biologics and injectable drugs. [See CDMO profile]

  • Reig Jofre: Injectable (lyo and liquid) and liquid manufacturing facilities. [See CDMO]

  • Pharmaloop: Fully integrated CDMO solutions for Blow-Fill-Seal (BFS), sterile multidose, non-sterile multi-dose, sachets, capsules and tablets. [See CDMO profile]

  • Glatt Pharmaceutical Services GmbH Co. & KG: cGMP-compliant CDMO for end-to-end services in complex oral solid dosage forms. [See CDMO profile]

  • Adragos Pharma: Over 100 years of experience delivering customer-focused manufacturing and first-class service. [See CDMO profile]

  • CARBOGEN AMCIS: Highly potent APIs development and small-scale cGMP production including chromatography and lyophilization. [See CDMO profile]

  • Apeloa Pharmaceutical Co., Ltd: Development and manufacturing of APIs, intermediates and registered starting materials. [See CDMO profile]

  • Mabion cGMP Facility: Development and GMP manufacturing of biotherapeutics including monoclonal antibodies and recombinant protein products. [See CDMO profile]

  • Ophtapharm, a Sentiss Company: Ophthalmic and otic solutions, suspensions, emulsions, ointments and gels. FDA-approved facility. [See CDMO profile]

  • Cellex Cell Professionals: CGT CDMO specialized in cell manufacturing and collection of starting materials. [See CDMO profile]

  • AdhexPharma SAS: CDMO for transdermal patches and oromucosal films. [See CDMO profile]

  • MENADIONA S.L: APIs, intermediates and fine chemicals; specialized in transferring R&D projects into full cGMP manufacturing. [See CDMO profile]

  • Content Group: Tubilux Pharma manufacturing facility. [See CDMO profile]

  • TRADICHEM INDUSTRIAL SERVICES: HIPERING® technology enabling lean manufacturing. [See CDMO profile]

  • 53Biologics Production Plant: Biologics production from DNA to proteins, from preclinical to cGMP manufacturing. [See CDMO profile]

  • Rioja Nature Pharma: CDMO specializing in nutraceuticals and food supplements. [See CDMO profile]

  • HIPRA BIOTECH SERVICES: End-to-end capabilities from cell line development to commercial manufacturing. [See CDMO profile]

  • Skyepharma: Development and delivery of oral technologies for pharma, biotech and consumer health. [See CDMO profile]

  • ChemCon GmbH: CDMO for APIs and fine chemicals with expertise in scaling R&D projects to cGMP manufacturing. [See CDMO profile]

  • VIVEbiotech: GMP-certified CDMO dedicated to lentiviral vector production. [See CDMO profile]

  • BAG Health Care: Parenteral fill & finish for vials in small to mid-size batches and investigational products. [See CDMO profile]

  • Lannett CDMO: OSD and liquid manufacturing capabilities in Seymour, Indiana. [See CDMO profile]

  • Basic Pharma Manufacturing: Analytical testing and regulatory support tailored to project needs. [See CDMO profile]

  • HISTOCELL S.L: Developer and manufacturer of cell therapies (iPSCs, MSCs, secretomes, exosomes) plus medical devices and dermocosmetics. [See CDMO profile]

  • Lukas Heil-Betriebsstätte: High-performance GMP facility for sterile and aseptic liquids, especially glass ampoules. [See CDMO profile]

  • Laboratori Alchemia SRL: Production from lab scale for complex synthetic products to hundreds of kilograms per year. [See CDMO profile]

  • Cambrex: Specialists in late-phase and commercial API development and cGMP manufacturing. [See CDMO profile]

  • Aenova Group: Competence center for solids, semisolids, liquids and clinical services. [See CDMO profile]

  • Pharmaron: Commercial small molecule API synthesis. [See CDMO profile]

  • Darnytsia Kyiv: Advanced facilities, strict quality control and expert staff for reliable, compliant solutions. [See CDMO profile]

  • White Raven: Fill & finish site dedicated to GMP formulation and aseptic filling of sterile liquid injectables. [See CDMO profile]

  • Sidefarma: Specialist in small and medium batch manufacturing for regulated markets following EU quality standards. [See CDMO profile]

  • Sylentis: Oligonucleotide manufacturer. [See CDMO profile]

These CDMOs combine quality infrastructure with regulatory experience to ensure EU market success.

Related Information

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Let MAI CDMO Help You Find the Right EMA EU GMP CDMO Partner

At MAI CDMO, we connect pharma and biotech companies with the most qualified EMA EU GMP CDMO companies offering world-class European pharmaceutical manufacturing services. Whether you´re preparing for an EU clinical trial, submitting a marketing authorization application, or scaling to commercial supply, we’ll help you find a trusted partner to ensure EU-GMP compliance every step of the way.

 

Need an EU-compliant manufacturing solution? Contact us today and find your ideal European CDMO partner.

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Salvat
Shilpa Biologicals
CGAM
Pharmaron
Ascil
Lannett