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Biologics CDMO Companies | Biopharmaceutical Contract Manufacturing

Your Trusted Partners for Biopharmaceutical Contract 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
Advanced Protein Production
United States North America
Advanced Protein Production 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 North America
CHEMICAL-SYNTHETIC NUTRACEUTICALS SERVICES in North America Discover our facility

Your trusted CRO/CDMO Partner

  • Activity: CHEMICAL-SYNTHETIC, NUTRACEUTICALS, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • 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: 1 - 100 L, Small, Batch, Fed-batch
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2
  • Markets: N/A
Cambrex Wiesbaden
Germany Europe
Cambrex Wiesbaden Discover our facility

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

  • Activity: BIOLOGICS, Peptide, protein, hormone & enzyme manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • 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: Batch certification / release, Analytical methods...
  • 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: CMC regulatory support, Tech transfer, Analytical...
  • 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, Distribution,...
  • 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: Investigational, Preclinical, 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)
OLIGONUCLEOTIDES in Europe
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Spain Europe
FDF / DRUG PRODUCTS in Europe Discover our facility

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

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP)
  • Services: 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, 2
  • Markets: EMA (EU)
VIVUNT PHARMA
Spain Europe
VIVUNT PHARMA Discover our facility

CDMO Sterile Oncology Drugs

  • Activity: Injectables, FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • 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)
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: Investigational, Preclinical, Phase I, Commercial...
  • 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, 100 - 1000 L, Medium, 1000 -...
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2
  • Markets: N/A
Ophtapharm, a Sentiss Company
Switzerland Europe
Ophtapharm, a Sentiss Company Discover our facility

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

  • Activity: Sterile forms (ophtalmic, nasal, otic), FDF / DRUG... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • 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: 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)
  • 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)
Skyepharma
France Europe
Skyepharma Discover our facility

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

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), World Health...
  • Services: Tech transfer, Primary packaging, Storage, R&D,...
  • 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...
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: Investigational, Preclinical, Phase I, Phase II,...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP)
  • Services: Tech transfer, Batch certification / release,...
  • Batch Size / Reactor: Small, Medium, Large
  • 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)
Viswa Laboratories Pvt Ltd
India APAC
Viswa Laboratories Pvt Ltd Discover our facility

CRAMS/CDMO, APIs, Intermediates and specialty chemicals

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (C) Cardiovascular system, (D) Dermatologicals,...
  • Certifications: World Health Organization (GMP / HACCP)
  • Services: Tech transfer, R&D, 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: R&D, 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), 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)
Aenova Group - Location Killorglin, Ireland
Ireland Europe
Aenova Group - Location Killorglin, Ireland Discover our facility

Competence Center for modified release pellets.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS,... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), MFDS/KFDA (Republic of Korea...
  • Services: N/A
  • 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...
BDI biotech Production Plant
Spain Europe
BDI biotech Production Plant Discover our facility

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

  • Activity: BIOLOGICS, Peptide, protein, hormone & enzyme, LBP... manufacturing
  • Uses: Investigational, Preclinical
  • Therapeutic areas: N/A
  • Certifications: ISO
  • Services: Upstream, Tech transfer, Analytical methods...
  • Batch Size / Reactor: 1 - 100 L, Small, Batch, Fed-batch, 100 - 1000 L,...
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1
  • Markets: FDA (USA), EMA (EU), MHRA (UK), Health Canada...
Liof Pharma S.L.U.
Spain Europe
Liof Pharma S.L.U. Discover our facility

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

  • Activity: FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • 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: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: Tech transfer, Primary packaging, Secondary...
  • Batch Size / Reactor: Small, Medium, Large
  • 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...
Cambrex Waltham (Snapdragon Chemistry)
United States North America
Cambrex Waltham (Snapdragon Chemistry) Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • 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), MHRA (UK),...
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
Aenova Group - Location Sisseln, Switzerland
Switzerland Europe
Aenova Group - Location Sisseln, Switzerland Discover our facility

Competence Center complex conventional solids.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS,... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • 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: Investigational, Preclinical, Phase I, Phase II
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: CMC regulatory support, Tech transfer, Analytical...
  • 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: Investigational, Preclinical, Phase I, Phase II,...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: 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),...
Aenova Group - Location Gronau, Germany
Germany Europe
Aenova Group - Location Gronau, Germany Discover our facility

Competence center for conventional solids and clinical services.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: Analytical methods development, Primary packaging,...
  • 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: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: N/A
  • Certifications: ISO, FDA (cGMP), 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: 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: FDF / DRUG PRODUCTS, Topical, mucosal and... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: (D) Dermatologicals, (H) Systemic hormonal...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP)
  • Services: Tech transfer, Analytical methods development,...
  • 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: Investigational, Preclinical, 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: 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), MHRA (UK),...
CARBOGEN AMCIS | Neuland
Switzerland Europe
CARBOGEN AMCIS | Neuland Discover our facility

Development and medium scale manufacturing

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: N/A
  • Certifications: FDA (cGMP), 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: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
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Switzerland Europe
FDF / DRUG PRODUCTS in Europe Discover our facility

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

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU 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: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
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: Tech transfer, Analytical methods development,...
  • 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: Investigational, Preclinical, 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),...
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Germany Europe
FDF / DRUG PRODUCTS in Europe 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)
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: Investigational, Preclinical
  • Therapeutic areas: N/A
  • Certifications: ISO
  • Services: Upstream, Tech transfer, R&D, Downstream, Pilot...
  • Batch Size / Reactor: 1 - 100 L, Small, Batch, Fed-batch, 100 - 1000 L,...
  • 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),...
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: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: (G) Genito urinary system and sex hormones, (H)...
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-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: 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: Investigational, Preclinical, Phase I, Commercial...
  • 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: Tech transfer, Analytical methods development,...
  • 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),...
Actylis Eugene
United States North America
Actylis Eugene Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, FDA (cGMP)
  • Services: Tech transfer, Analytical methods development,...
  • 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, BIOLOGICS, Sterile forms (ophtalmic,... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • 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,...
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, FDF / DRUG... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • 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...
Cambrex Charles City
United States North America
Cambrex Charles City Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: N/A
  • 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), MHRA (UK),...
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Japan APAC
FDF / DRUG PRODUCTS in APAC Discover our facility

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

  • Activity: Injectables, Oral solids / OSD, FDF / DRUG... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), PMDA/MHLW (Japan GMP)
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Large
  • 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 in APAC
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Germany Europe
FDF / DRUG PRODUCTS in Europe Discover our facility

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

  • Activity: FDF / DRUG PRODUCTS, Topical, mucosal and... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • 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: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
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: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: Primary packaging, Storage, CMC regulatory...
  • Batch Size / Reactor: 1 - 100 L, Small, Batch, 100 - 1000 L, Medium,...
  • 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),...
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),...
Aenova Group - Location Regensburg, Germany
Germany Europe
Aenova Group - Location Regensburg, Germany Discover our facility

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

  • Activity: Oral solids / OSD, Oral liquids and semisolids,... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • 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), MFDS (South...
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: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: Upstream, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Batch, 1 - 100 L, Small, Fed-batch, 100 - 1000 L,...
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU), MHRA (UK), Health Canada...
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),...
Pharmaron API Commercial Synthesis Shaoxing (China)
China APAC
Pharmaron API Commercial Synthesis Shaoxing (China) Discover our facility

Commercial API Small Molecules /Peptides Synthesis

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • 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)
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France Europe
FDF / DRUG PRODUCTS in Europe Discover our facility

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

  • Activity: Injectables, FDF / DRUG PRODUCTS, Topical, mucosal... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)
  • Services: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small, Medium, Large
  • 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),...
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: 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)
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Apeloa Pharmaceutical Co., Ltd.
China APAC
Apeloa Pharmaceutical Co., Ltd. Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • 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),...
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United States North America
CHEMICAL-SYNTHETIC in North America Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, FDA (cGMP), NSF
  • Services: CMC regulatory support, Tech transfer, Analytical...
  • 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: Storage, Primary packaging, Secondary packaging,...
  • 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...
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: Investigational, Preclinical, Phase I, Phase II,...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP)
  • Services: Batch certification / release, Upstream, Tech...
  • Batch Size / Reactor: Small, 1 - 100 L, Medium
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), 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: Investigational, Preclinical, Phase I, Commercial...
  • 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...
i+Med | Drug products
Spain Europe
i+Med | Drug products Discover our facility

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

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Investigational, Preclinical, Phase I
  • Therapeutic areas: (A) Digestive tract and metabolism, (D)...
  • Certifications: ISO
  • 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, 3, 4
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Pharmaron API Commercial Synthesis Coventry (US)
United States North America
Pharmaron API Commercial Synthesis Coventry (US) Discover our facility

Commercial API Small Molecules Synthesis

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • 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),...
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: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: CMC regulatory support, Tech transfer, Analytical...
  • 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, FDF / DRUG PRODUCTS, Oral liquids and... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: EMA (EU GMP), Health Canada (Canada GMP),...
  • Services: CMC regulatory support, Tech transfer, Analytical...
  • 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: 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),...
SINOWAY INDUSTRIAL CO., LTD
China APAC
SINOWAY INDUSTRIAL CO., LTD Discover our facility

One-stop CDMO Solutions for APl and Key intermediates

  • Activity: ATMP (Advanced Therapies), Injectables,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, FDA (cGMP), World Health Organization (GMP /...
  • Services: R&D, Pilot plant, Scale-up, Formulation mixing,...
  • Batch Size / Reactor: 1 - 100 L, Batch, 100 - 1000 L, Fed-batch,...
  • DEA: Schedule III (lower potential for abuse)
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
  • BSL: 1, 2, 3, 4
  • Markets: 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: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Tech transfer, Analytical methods development,...
  • 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),...
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: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Upstream, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Batch, 1 - 100 L, Small, Fed-batch, 100 - 1000 L,...
  • 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),...
i+Med | Cosmetics, Nutraceutics & Medical Devices
Spain Europe
i+Med | Cosmetics, Nutraceutics & Medical Devices Discover our facility

Developer and manufacturer of new products in the field of biomedical engineering with control release technologies.

  • Activity: COSMETICS, NUTRACEUTICALS manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: (A) Digestive tract and metabolism, (D)...
  • Certifications: ISO
  • 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, 3, 4
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
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), FDF /... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Primary packaging, Storage, Upstream, Tech...
  • Batch Size / Reactor: Batch, 1 - 100 L, Small, Fed-batch, 100 - 1000 L,...
  • 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),...
FDF / DRUG PRODUCTS BIOLOGICS in Europe
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Norway Europe
FDF / DRUG PRODUCTS in Europe Discover our facility

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

  • Activity: Injectables, FDF / DRUG PRODUCTS, Topical, mucosal... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • 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...
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: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: (G) Genito urinary system and sex hormones, (H)...
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Storage, CMC regulatory support, Tech transfer,...
  • 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),...
CARBOGEN AMCIS | Bubendorf
Switzerland Europe
CARBOGEN AMCIS | Bubendorf Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC, BIOLOGICS, ADC & NDC... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • 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: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: NMPA (China GMP), 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), NMPA (China),...
Adare Pharma | US
United States North America
Adare Pharma | US Discover our facility

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

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS, SERVICES manufacturing
  • Uses: N/A
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: CMC regulatory support, Tech transfer, Analytical...
  • 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: Investigational, Preclinical, Phase I, Commercial...
  • 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),...
Adare Pharma | EU
Italy Europe
Adare Pharma | EU Discover our facility

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

  • Activity: Oral solids / OSD, 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: CMC regulatory support, Tech transfer, Analytical...
  • 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: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • 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)
  • BSL: N/A
  • 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: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Storage, 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: 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),...
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: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO
  • Services: Batch certification / release, Primary packaging,...
  • Batch Size / Reactor: Batch, 1 - 100 L, Small, Fed-batch, 100 - 1000 L,...
  • 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 | Veenendaal
Netherlands Europe
CARBOGEN AMCIS | Veenendaal Discover our facility

Large scale manufacturing of Cholesterol and Vitamin D analogs.

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Phase I, Commercial...
  • 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),...
Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site
China APAC
Sichuan Huiyu Pharmaceuticals Co., Ltd. - Formulation Manufacturing Site 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: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: 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),...
Sichuan Huiyu Pharmaceuticals Co., Ltd. - API Manufacturing Site
China APAC
Sichuan Huiyu Pharmaceuticals Co., Ltd. - API Manufacturing Site 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: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: 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),...
Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site
China APAC
Sichuan Huiyu Pharmaceuticals Co., Ltd. - R&D Site 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: Investigational, Preclinical, Phase I, Commercial...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: 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),...

The market for complex biologics is booming, with innovative therapies demanding specialized large molecule manufacturing expertise, yet the path from cell-line development to commercial launch is anything but simple. Partnering with experienced biologics CDMO companies, experts in biopharmaceutical contract manufacturing, gives emerging and established innovators the speed, compliance, and specialized know-how they need to transform breakthrough science into approved biopharmaceutical products.

How to Choose a Biologics CDMO

Selecting the right partner for outsourced biologics production is critical to your molecule’s success. The ideal biologics contract development and manufacturing organization should offer:

  • Regulatory track record: Confirm recent FDA/EMA inspections and cGMP certifications for biologic drugs.
  • Technical fit: Proven platforms for your molecule type (mAbs, recombinant proteins, viral vectors, vaccines) and similar biotherapeutics.
  • Scale-up flexibility: From 50 L perfusion to 20,000 L fed-batch — can they grow with you through clinical phases to commercial scale?
  • Analytical depth: In-house bioassays, mass spec, and process analytics shorten batch release timelines.
  • Culture & communication: Transparent project management and digital data-sharing tools keep cross-functional teams aligned.

Request tech transfer statistics, batch success rates, and real client references to benchmark biomanufacturing performance.

Key Services Offered by Biologics Contract Manufacturers

Leading providers go far beyond stainless-steel bioreactors to deliver end-to-end solutions. Core offerings typically include:

  • Cell-line & process development – high-throughput clone screening, media optimization, and QbD studies for robust processes.
  • Upstream & downstream manufacturing – single-use or hybrid suites, continuous processing, high-capacity chromatography, and viral-clearance steps tailored to your biologic product.
  • Fill-finish & formulation – aseptic vial, syringe, or cartridge filling plus lyophilization and advanced delivery systems.
  • Analytical & QC services – stability programs, impurity profiling, potency assays, and real-time release testing meeting global standards.
  • Regulatory & CMC support – IND/BLA dossier authoring, comparability protocols, and global tech transfer for seamless approvals.

Advantages of Partnering with Biologics CDMOs

  • Speed to clinic: Established platform processes can cut development timelines by 6–12 months versus in-house development.
  • CapEx avoidance: Outsourcing eliminates the multimillion-dollar investment and validation burden of building dedicated facilities.
  • Scalability: Seamless transition from pilot to commercial volume within one network reduces supply-chain risk.
  • Specialized talent: Access to seasoned upstream scientists, viral safety experts, and regulatory strategists with biologic-specific experience.
  • Global reach: Multi-site biologics CDMOs offer redundant capacity, regional fill-finish options, and worldwide cold chain logistics support.

Top Biologics CDMO Companies

  • Mabion: A fully integrated biologics CDMO offering services from development to GMP manufacturing of biotherapeutics, including monoclonal antibodies and recombinant proteins. [See CDMO profile]
  • HIPRA BIOTECH SERVICES: End-to-end biopharmaceutical contract manufacturing capabilities, from cell line development to commercial production. [See CDMO profile]
  • Shilpa Biologicals: Supporting process development, gene-to-cell line development, GMP, formulation development, analytical development, drug substance, drug product, fill-finish, and packaging. [See CDMO profile]
  • 53Biologics: Specialized in biopharmaceutical contract manufacturing from DNA to proteins, covering preclinical to cGMP manufacturing. [See CDMO profile]
  • Rodon Biologics: Providing excellence in biopharmaceutical product development for third parties. [See CDMO profile]
  • Histocell: A biologics CDMO developing exosomes and secretomes as part of cell therapies. [See CDMO profile]
  • VIVEbiotech: GMP-certified CDMO exclusively dedicated to lentiviral vector production. [See CDMO profile]
  • Cultiply: Developing production and purification processes for recombinant proteins, enzymes, DNA, and other bioderived products. [See CDMO profile]
  • BDI biotech: R&D-focused CDMO specializing in strain and bioprocess development, scale-up, and batch production. [See CDMO profile]

Related Information

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ChemCon
Liof Pharma
VIVUNT
Cambrex
Shilpa Biologicals
Lannett