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Commercial CDMO Companies | Commercial Contract Manufacturing Services

Your Trusted Partners for Commercial Contract Manufacturing and Development

  
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
France Europe
in Europe Discover our facility

Custom development and automated aseptic production of liquid and lyophilized drug product

  • 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
United Kingdom Europe
in Europe Discover our facility

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

  • 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
Netherlands Europe
in Europe Discover our facility

Large scale manufacturing of Cholesterol and Vitamin D analogs

  • 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
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
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
Germany Europe
Cambrex Wiesbaden Discover our facility

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

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

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

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

Competence Center Packaging Solids.

  • Activity: NUTRACEUTICALS manufacturing
  • Uses: Investigational, Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: FDA (cGMP), Health Canada (Canada GMP), Halal...
  • Services: Primary packaging, Storage, Secondary packaging,...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: FDA (USA), Health Canada (Canada)
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: 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)
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, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), French Service-Public...
  • Services: Upstream, Downstream, Cell line development, Cell...
  • Batch Size / Reactor: Small, 1 - 100 L, Medium, 100 - 1000 L, Large,...
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1, 2
  • Markets: N/A
Spain Europe
VIVUNT PHARMA Discover our facility

CDMO Sterile Oncology Drugs

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

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

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

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

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

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

  • Activity: BIOLOGICS, Peptide, protein, hormone & enzyme, LBP... manufacturing
  • Uses: Investigational, Preclinical
  • Therapeutic areas: N/A
  • Certifications: ISO
  • Services: R&D, Upstream, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Medium, Fed-batch, 100 -...
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: 1
  • Markets: FDA (USA), EMA (EU), MHRA (UK), Health Canada...
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, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), World Health Organization (GMP /...
  • Services: Batch certification / release, R&D, Primary...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Medium, Fed-batch, 100 -...
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2
  • Markets: EMA (EU)
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, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), World Health Organization (GMP /...
  • Services: Batch certification / release, R&D, Upstream, Tech...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Medium, Fed-batch, 100 -...
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2, 3
  • Markets: EMA (EU)
India APAC
Viswa Laboratories Pvt Ltd Discover our facility

CRAMS/CDMO, APIs, Intermediates and specialty chemicals

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (C) Cardiovascular system, (D) Dermatologicals,...
  • Certifications: World Health Organization (GMP / HACCP)
  • Services: R&D, Tech transfer, Pilot plant, Scale-up, Clean...
  • Batch Size / Reactor: Small, Medium, Large
  • 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...
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, FDF / DRUG PRODUCTS, Oral... 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)
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)
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...
Spain Europe
Liof Pharma S.L.U. Discover our facility

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

  • Activity: FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: Tech transfer, Batch certification / release,...
  • Batch Size / Reactor: N/A
  • 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),...
Italy Europe
Aenova Group - Location Carugate, Italy Discover our facility

Competence Center Semisolids and non-sterile liquids.

  • Activity: FDF / DRUG PRODUCTS, Oral liquids and semisolids,... 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),...
Germany Europe
Aenova Group - Location Marburg, Germany Discover our facility

Competence Center complex conventional solids and narcotics.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: Tech transfer, Primary packaging, Secondary...
  • Batch Size / Reactor: Small, Medium, Large
  • 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...
Germany Europe
Aenova Group - Location Feldkirchen, Germany Discover our facility

Competence Center Semisolids and Liquids.

  • Activity: FDF / DRUG PRODUCTS, Oral liquids and semisolids,... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (D) Dermatologicals, (J) Antiinfectives for...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Roszdravnadzor...
  • 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), Russian Health Authorities
United States North America
Cambrex Waltham (Snapdragon Chemistry) Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium
  • 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),...
Italy Europe
Laboratori Alchemia SRL Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: N/A
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), World Health Organization (GMP /...
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium
  • 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),...
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: R&D, Upstream, Tech transfer, Downstream, Pilot...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, 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),...
Switzerland Europe
Aenova Group - Location Sisseln, Switzerland Discover our facility

Competence Center complex conventional solids.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, FDA (cGMP), World Health Organization (GMP /...
  • Services: Tech transfer, Primary packaging, Secondary...
  • Batch Size / Reactor: Small, Medium, Large
  • 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...
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...
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, FDF / DRUG... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Storage, R&D, CMC regulatory support, Tech...
  • Batch Size / Reactor: Small
  • 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),...
Switzerland Europe
CARBOGEN AMCIS | Vionnaz Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II,...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: R&D, Analytical methods development, Batch...
  • Batch Size / Reactor: Small
  • 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),...
Germany Europe
Aenova Group - Location Gronau, Germany Discover our facility

Competence center for conventional solids and clinical services.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small, Medium, Large
  • 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),...
Switzerland Europe
CARBOGEN AMCIS | Aarau Discover our facility

Development and medium scale cGMP manufacturing including chromatography

  • Activity: BIOLOGICS, CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, FDA (cGMP), World Health Organization (GMP /...
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium
  • 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),...
China APAC
CARBOGEN AMCIS | Shanghai, China Discover our facility

Large scale manufacturing.

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: N/A
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), World Health Organization (GMP...
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: N/A
  • 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),...
United States North America
Cambrex Durham Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small
  • 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),...
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),...
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),...
Switzerland Europe
CARBOGEN AMCIS | Neuland Discover our facility

Development and medium scale manufacturing

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: FDA (cGMP), World Health Organization (GMP /...
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium
  • 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),...
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),...
Estonia Europe
Cambrex Tallinn Discover our facility

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

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

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

  • Activity: BIOLOGICS, Abs (Antibodies), ADC & NDC... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: R&D, Batch certification / release, Primary...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Medium, 100 - 1000 L,...
  • 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),...
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, Commercial (Phase...
  • Therapeutic areas: (G) Genito urinary system and sex hormones, (H)...
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: CMC regulatory support, R&D, Tech transfer,...
  • Batch Size / Reactor: Small, Medium
  • 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),...
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, 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...
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),...
United States North America
Actylis Eugene Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, FDA (cGMP)
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium
  • 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...
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, 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: 1, 2
  • Markets: FDA (USA), EMA (EU), Turkish Health Authorities,...
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, Commercial (Phase...
  • Therapeutic areas: (J) Antiinfectives for systemic use
  • Certifications: EMA (EU GMP), ECOVADIS, World Health Organization...
  • Services: CMC regulatory support, Tech transfer, Analytical...
  • 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...
United States North America
Cambrex Charles City Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium, Large
  • 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),...
Germany Europe
ChemCon GmbH Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (C) Cardiovascular system, (N) Nervous system, (R)...
  • Certifications: EMA (EU GMP), FDA (cGMP), ECOVADIS
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium
  • 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),...
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, FDF / DRUG PRODUCTS, Oral... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium, Large
  • 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...
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: Tech transfer, Batch certification / release,...
  • 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),...
China APAC
Pharmaron Shaoxing Site (China) Discover our facility

Small Molecule (RSM/APIs) / Peptide Commercial Facility

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, NMPA (China GMP)
  • Services: Tech transfer, Pilot plant, Scale-up, Pilot...
  • 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),...
Spain Europe
HISTOCELL S.L. | Cell Therapy, Exosomes & Secretomes Discover our facility

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

  • Activity: Cell therapy, ATMP (Advanced Therapies),... manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II,...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP)
  • Services: R&D, Tech transfer, Analytical methods...
  • 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),...
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: Storage, CMC regulatory support, R&D, Tech...
  • 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),...
United States North America
CHEMICAL-SYNTHETIC in North America Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, FDA (cGMP), NSF
  • Services: R&D, Storage, CMC regulatory support, Tech...
  • Batch Size / Reactor: Small
  • 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)
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...
Switzerland Europe
Aenova Group - Location Kirchberg, Switzerland Discover our facility

Competence Center Soft gelatin capsules.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS, COSMETICS,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: R&D, Tech transfer, Primary packaging, Secondary...
  • Batch Size / Reactor: Small, Medium, Large
  • 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...
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: 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),...
United States North America
Pharmaron Coventry Site (US) Discover our facility

Small Molecule (RSM/APIs) Commercial Facility

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, FDA (cGMP), ECOVADIS
  • Services: Tech transfer, Pilot plant, Scale-up, Process...
  • Batch Size / Reactor: Small, Medium, Large
  • 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),...
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, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: EMA (EU GMP), Health Canada (Canada GMP),...
  • Services: Primary packaging, R&D, CMC regulatory support,...
  • Batch Size / Reactor: Medium, Large
  • 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...
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, FDF / DRUG PRODUCTS, Oral... manufacturing
  • Uses: Investigational, Commercial (Phase IV), Phase II,...
  • Therapeutic areas: (C) Cardiovascular system, (H) Systemic hormonal...
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Storage, R&D, CMC regulatory support, Tech...
  • Batch Size / Reactor: Small, Medium, Large
  • 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),...
Spain Europe
Grifols International | Barcelona Plant Discover our facility

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

  • Activity: Injectables, FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Storage, R&D, CMC regulatory support, Tech...
  • Batch Size / Reactor: Small, Medium, Large
  • 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),...
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, 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),...
Germany Europe
FDF / DRUG PRODUCTS BIOLOGICS SERVICES in Europe Discover our facility

Global CDMO partner, providing Development and Manufacturing services for drug products.

  • Activity: Injectables, BIOLOGICS, Abs (Antibodies), Sterile... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: Primary packaging, R&D, Storage, CMC regulatory...
  • 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),...
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, Commercial (Phase...
  • Therapeutic areas: (G) Genito urinary system and sex hormones, (H)...
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Primary packaging, R&D, Storage, CMC regulatory...
  • Batch Size / Reactor: Small, Medium, Large
  • 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),...
Switzerland Europe
CARBOGEN AMCIS | Bubendorf Discover our facility

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

  • Activity: BIOLOGICS, CHEMICAL-SYNTHETIC, ADC & NDC... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium
  • 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),...
United Kingdom Europe
Pharmaron Cramlington Site (UK) Discover our facility

Small Molecule (RSM/APIs) Commercial Facility

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Small, Medium, Large
  • 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),...
Spain Europe
FAES FARMA | DERIO facility Discover our facility

Developer and manufacturer of human medicinal products.

  • Activity: Sterile forms (ophtalmic, nasal, otic), Oral... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: CMC regulatory support, R&D, Tech transfer, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • 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),...
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, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO
  • Services: Analytical methods development, R&D, Batch...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Medium, Fed-batch, 100 -...
  • 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),...
Spain Europe
CHEMICAL-SYNTHETIC COSMETICS NUTRACEUTICALS SERVICES in Europe Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC, COSMETICS, NUTRACEUTICALS,... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), ECOVADIS, World...
  • Services: R&D, Tech transfer, Analytical methods...
  • Batch Size / Reactor: Medium, Large
  • 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),...
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, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Batch certification / release, R&D, Primary...
  • Batch Size / Reactor: Small, Medium, Large
  • 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),...
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, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Batch certification / release, R&D, Primary...
  • Batch Size / Reactor: Small, Medium, Large
  • 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),...
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, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Batch certification / release, R&D, Primary...
  • Batch Size / Reactor: Small, Medium, Large
  • 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),...

Bringing a pharmaceutical product to market requires a partner that can deliver consistent quality at scale. That’s where commercial CDMOs come in. These specialized providers offer the infrastructure, expertise, and regulatory readiness to handle full-scale production, packaging, and distribution—helping you transition seamlessly from development to commercialization.

Whether you’re launching a new drug or scaling up an existing one, commercial contract manufacturing services ensure reliable supply, regulatory compliance, and cost efficiency across global markets.


How to Choose a Commercial Contract Manufacturing Partner

Selecting the right commercial CDMO is crucial for product success. Beyond technical capabilities, look for a partner with:

  • Proven experience in commercial-scale manufacturing and global launches.

  • Regulatory track record with agencies like the FDA, EMA, and others.

  • Robust supply chain management, including sourcing, inventory control, and distribution.

  • Flexible capacity to support demand fluctuations and future growth.

  • Commitment to quality through rigorous GMP compliance and continuous improvement systems.

A successful commercial partnership is built on transparency, strategic alignment, and shared long-term goals.


Key Services Offered by Commercial CDMOs

Full-Scale GMP Manufacturing: High-volume commercial production across a range of dosage forms, including solid, liquid, sterile, and specialty formulations.

Technology Transfer & Process Validation: Transfer of late-stage processes into commercial environments with full validation and documentation.

Commercial Packaging & Serialization: Blistering, bottling, labeling, and serialization services for regulatory-compliant supply.

Stability & Release Testing: Ongoing quality control and ICH-compliant stability programs for commercial batches.

Global Logistics & Supply Chain Coordination: Warehousing, inventory management, and worldwide distribution solutions.


Advantages of Partnering with a Commercial CDMO

Accelerated Time to Market: Streamlined tech transfer and readiness to launch at scale.

Regulatory Confidence: Commercial CDMOs experienced in audits and submissions for multiple regulatory bodies worldwide.

Operational Efficiency: Lean manufacturing practices and automation drive cost control and consistency.

Risk Mitigation: Integrated quality systems reduce supply chain disruptions and ensure product reliability.

Scalability: Ability to adjust batch sizes and production schedules based on market demand.


Commercial Manufacturing CDMO Companies

Some of the top commercial CDMO companies:

  • Actylis: CDMO specialized in Chemical Process Discovery, Development, cGMP, and Commerical Manufacturing Services. [See CDMO profile]

  • Aenova: CDMO for high volume manufacturing of conventional solids. [See CDMO profile]

  • CDM Lavoisier: Commercial manufacturing of glass ampoules, glass vials and plastic (BFS) ampoules. [See CDMO profile]

  • Cambrex: CDMO that develops and manufactures proprietary products (generic APIs) and provides contract manufacturing services for intermediates and custom APIs at commercial scale. [See CDMO profile]

  • Lannett CDMO: Lannetts main manufacturing site includes capabilities for Oral Solid Dose (OSD) and Liquids. [See CDMO profile]

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

  • Viswa Laboratories: CRAMS/CDMO, APIs, Intermediates and specialty chemicals. [See CDMO profile]

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

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

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

  • Pharmaron: Small molecule (RSM/APIs) commercial facility. [See CDMO profile]

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

  • Shilpa Biologicals: CDMO which support Process Development, Gene to Cell Line Development to GMP to Formulation Development, Analytical Development, Process Development, Drug Substance Commercial Manufactuing, Drug Product, Fill-Finish and Packaging. [See CDMO profile]

  • Reig Jofre: Betalactam antibiotics (FDF) development and manufacturing state-of-the-art facilities. [See CDMO profile]

  • Mabion: Fully integrated CDMO offering a wide services associated with the development and GMP manufacturing of biotherapeutics, including commercial manufacturing. [See CDMO profile]

  • 53Biologics: CDMO specialized in decoding biologics production, from DNA to proteins, providing from preclinical to cGMP commercial manufacturing. [See CDMO profile]

  • VIVEbiotech: Your leading GMP-certified CDMO exclusively dedicated to the production of lentiviral vectors. [See CDMO profile]


Related Information

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Let MAI CDMO Help You Find the Right Commercial Manufacturing Partner

Choosing the right commercial CDMO is a strategic decision that impacts your product’s success on the market. MAI CDMO connects you with experienced commercial contract manufacturing partners tailored to your product, scale, and regulatory needs.

We work closely with you to understand your goals and identify commercial CDMOs with the technical capabilities, capacity, and compliance record to meet them.

 

Contact us today to explore commercial CDMO solutions and ensure your product reaches patients—on time, at scale, and with uncompromised quality.

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If you have any questions or suggestions, click here. We will be happy to assist you.

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ChemCon
Shilpa Biologicals
Cambrex
Lannett
CGAM
Grifols