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ATMP CDMO Companies | Advanced Therapies Contract Manufacturing Services

Your Trusted Partners for Advanced Therapies 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
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, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO
  • Services: N/A
  • Batch Size / Reactor: Small, Medium
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: N/A
Rodon Biologics
Portugal Europe
Rodon Biologics Discover our facility

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

  • Activity: Abs (Antibodies), BIOLOGICS, Peptide, protein,... manufacturing
  • Uses: Investigational
  • Therapeutic areas: N/A
  • Certifications: N/A
  • Services: Upstream, Downstream, Cell line development,...
  • Batch Size / Reactor: Small, Batch, 1 - 100 L, Fed-batch
  • 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, 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)
CARBOGEN AMCIS | Manchester, UK
United Kingdom Europe
CARBOGEN AMCIS | Manchester, UK Discover our facility

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

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

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

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

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

  • Activity: Injectables, FDF / DRUG PRODUCTS manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP)
  • Services: Analytical methods development, Batch...
  • 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: 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)
Sylentis
Spain Europe
Sylentis Discover our facility

Oligonucleotide manufacturer

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

CDMO Sterile Oncology Drugs

  • Activity: Injectables, FDF / DRUG PRODUCTS manufacturing
  • Uses: 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)
Ophtapharm, a Sentiss Company
Switzerland Europe
Ophtapharm, a Sentiss Company Discover our facility

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

  • Activity: Sterile forms (ophtalmic, nasal, otic), FDF / DRUG... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: Analytical methods development, Primary packaging,...
  • Batch Size / Reactor: Small, Medium, Large
  • 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: Primary packaging, CMC regulatory support, R&D,...
  • 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),...
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: Storage, CMC regulatory support, R&D, Upstream,...
  • 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...
Skyepharma
France Europe
Skyepharma Discover our facility

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

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), World Health...
  • Services: Primary packaging, Storage, R&D, Tech transfer,...
  • 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: Batch certification / release, Primary packaging,...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 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: R&D, Tech transfer, Pilot plant, Scale-up, Clean...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: Schedule III (lower potential for abuse)
  • Toxicity (OEB classification): 3 (PDE = 100 - 1,000 µg/day)
  • BSL: 2
  • Markets: EMA (EU), NMPA (China), CDSCO (India), ANVISA...
Aenova Group - Location Bad Aibling, Germany
Germany Europe
Aenova Group - Location Bad Aibling, Germany Discover our facility

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

  • Activity: Oral solids / OSD, Oral liquids and semisolids,... manufacturing
  • Uses: Commercial (Phase IV)
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), IFS
  • Services: 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...
Liof Pharma S.L.U.
Spain Europe
Liof Pharma S.L.U. Discover our facility

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

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

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium
  • 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: 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: N/A
  • Markets: EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK),...
Aenova Group - Location Feldkirchen, Germany
Germany Europe
Aenova Group - Location Feldkirchen, Germany Discover our facility

Competence Center Semisolids and Liquids.

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

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

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

Competence Center complex conventional solids.

  • Activity: Oral solids / OSD, FDF / DRUG PRODUCTS,... manufacturing
  • Uses: 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...
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: 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), MHRA (UK),...
CARBOGEN AMCIS | Vionnaz
Switzerland Europe
CARBOGEN AMCIS | Vionnaz Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Phase I, Phase II,...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: R&D, Analytical methods development, Batch...
  • Batch Size / Reactor: Small
  • 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, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), EDE (UAE),...
CARBOGEN AMCIS | Aarau
Switzerland Europe
CARBOGEN AMCIS | Aarau Discover our facility

Development and medium scale cGMP manufacturing including chromatography

  • Activity: CHEMICAL-SYNTHETIC, BIOLOGICS, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, FDA (cGMP), World Health Organization (GMP /...
  • Services: Analytical methods development, Batch...
  • 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, Commercial (Phase...
  • Therapeutic areas: (D) Dermatologicals, (H) Systemic hormonal...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP)
  • Services: Analytical methods development, R&D, Tech...
  • Batch Size / Reactor: Small, Medium, Large
  • 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: Analytical methods development, Batch...
  • 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: Analytical methods development, Batch...
  • 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, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: FDA (cGMP), World Health Organization (GMP /...
  • Services: Analytical methods development, Batch...
  • 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: Analytical methods development, Batch...
  • 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: Analytical methods development, Batch...
  • Batch Size / Reactor: Small
  • DEA: Schedule I (high potential for abuse / no medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
CHEMICAL-SYNTHETIC SERVICES in Europe
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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)
53Biologics Production Plant
Spain Europe
53Biologics Production Plant Discover our facility

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

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

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

  • Activity: Abs (Antibodies), BIOLOGICS, ADC & NDC... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: Upstream, Tech transfer, Analytical methods...
  • 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),...
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, Commercial (Phase...
  • Therapeutic areas: (G) Genito urinary system and sex hormones, (H)...
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium
  • 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, Commercial (Phase...
  • Therapeutic areas: (H) Systemic hormonal preparations excl. sex...
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: Primary packaging, Secondary packaging, Labeling,...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), MFDS (South Korea), Turkish...
Cambrex High Point
United States North America
Cambrex High Point Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Commercial (Phase IV), Phase I,...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Analytical methods development, Batch...
  • 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, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, FDA (cGMP)
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium
  • DEA: Schedule III (lower potential for abuse), Schedule...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), MHRA (UK), Health Canada...
Aenova Group - Location Latina, Italy
Italy Europe
Aenova Group - Location Latina, Italy Discover our facility

Competence Center animal health products and sterile technologies.

  • Activity: Injectables, Sterile forms (ophtalmic, nasal,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), ANVISA (Brazil B-GMP),...
  • Services: CMC regulatory support, R&D, Tech transfer,...
  • Batch Size / Reactor: Small, Medium, Large
  • 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, Oral liquids and... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (J) Antiinfectives for systemic use
  • Certifications: EMA (EU GMP), ECOVADIS, World Health Organization...
  • Services: Analytical methods development, Batch...
  • 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, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • 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),...
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: Batch certification / release, CMC regulatory...
  • 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, 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...
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: CMC regulatory support, Tech transfer, Batch...
  • 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, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, FDA (cGMP), NMPA (China GMP)
  • Services: Batch certification / release, CMC regulatory...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), NMPA (China)
Cenexi SAS
France Europe
Cenexi SAS Discover our facility

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

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

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

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

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

  • Activity: 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: Upstream, 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),...
FDF / DRUG PRODUCTS BIOLOGICS COSMETICS SERVICES in Europe
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United States North America
CHEMICAL-SYNTHETIC in North America Discover our facility

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

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, FDA (cGMP), NSF
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small
  • DEA: Schedule I (high potential for abuse / no medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2
  • Markets: FDA (USA)
Grifols International | Murcia Plant
Spain Europe
Grifols International | Murcia Plant Discover our facility

Sterile manufacturing solutions (small molecules) in flexible bags

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

Competence Center Soft gelatin capsules.

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

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

  • Activity: Abs (Antibodies), BIOLOGICS, Peptide, protein,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Upstream, Tech transfer, Analytical methods...
  • 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: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
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: 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: 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, 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),...
HIPRA BIOTECH SERVICES | Amer
Spain Europe
HIPRA BIOTECH SERVICES | Amer Discover our facility

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

  • Activity: Injectables, Abs (Antibodies), BIOLOGICS, Peptide,... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Upstream, Tech transfer, Analytical methods...
  • 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: FDA (USA), EMA (EU), PMDA (Japan), MHRA (UK),...
Laboratorio REIG JOFRE, SA (BARCELONA PLANT)
Spain Europe
Laboratorio REIG JOFRE, SA (BARCELONA PLANT) Discover our facility

Injectable (lyo and liquid) and Liquid manufacturing facilities

  • Activity: Injectables, Oral liquids and semisolids, FDF /... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: EMA (EU GMP), Health Canada (Canada GMP),...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Medium, Large
  • 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: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: Schedule I (high potential for abuse / no medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Adragos Pharma
Germany Europe
Adragos Pharma Discover our facility

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

  • Activity: Injectables, Abs (Antibodies), Sterile forms... manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: N/A
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • 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),...
Grifols International | Barcelona Plant
Spain Europe
Grifols International | Barcelona Plant Discover our facility

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

  • Activity: Injectables, FDF / DRUG PRODUCTS manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • 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),...
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, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (D)...
  • Certifications: ISO
  • 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: 1, 2, 3, 4
  • 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, Commercial (Phase...
  • Therapeutic areas: (G) Genito urinary system and sex hormones, (H)...
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • 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, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), World Health...
  • Services: Batch certification / release, CMC regulatory...
  • Batch Size / Reactor: Small, Medium
  • 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, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: NMPA (China GMP), ANVISA (Brazil B-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: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Pharmaron API Commercial Synthesis Cramlington (UK)
United Kingdom Europe
Pharmaron API Commercial Synthesis Cramlington (UK) Discover our facility

Commercial API Small Molecules Synthesis

  • Activity: CHEMICAL-SYNTHETIC manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: EMA (EU GMP), FDA (cGMP), Health Canada (Canada...
  • Services: Batch certification / release, CMC regulatory...
  • Batch Size / Reactor: Small, Medium, Large
  • 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 SERVICES in APAC Discover our facility

Synfine Drugs

  • Activity: CHEMICAL-SYNTHETIC, FDF / DRUG PRODUCTS, SERVICES 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),...
FAES FARMA | DERIO facility
Spain Europe
FAES FARMA | DERIO facility Discover our facility

Developer and manufacturer of human medicinal products.

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

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

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

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

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

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

  • Activity: Injectables, FDF / DRUG PRODUCTS, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (C)...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • 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: Batch certification / release, Primary packaging,...
  • Batch Size / Reactor: Medium, Large
  • DEA: Schedule IV (low potential for abuse), Schedule V...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
CARBOGEN AMCIS | Veenendaal
Netherlands Europe
CARBOGEN AMCIS | Veenendaal Discover our facility

Large scale manufacturing of Cholesterol and Vitamin D analogs.

  • Activity: CHEMICAL-SYNTHETIC, SERVICES manufacturing
  • Uses: Investigational, Preclinical, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small
  • 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, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • 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, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • 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, Commercial (Phase...
  • Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and...
  • Certifications: ISO, EMA (EU GMP), FDA (cGMP), Health Canada...
  • Services: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium, Large
  • 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),...

As cell, gene, and tissue-based therapies continue to redefine the frontiers of medicine, specialized ATMP CDMO companies have become essential partners in bringing these complex treatments to life. Advanced therapy medicinal products (ATMPs), including CAR-T cells, stem cell therapies, and gene-modified treatments, demand state-of-the-art manufacturing, rigorous compliance, and customized development approaches.

Whether you´re a biotech startup developing a first-in-class gene therapy or a pharma company scaling a tissue-engineered product, working with a trusted provider of advanced therapies contract manufacturing ensures your innovation moves smoothly from concept to clinic.

How to Choose ATMP CDMO Companies

Not all CDMOs are equipped for advanced therapies. Here’s what to consider when selecting an ATMP CDMO:

  • Regulatory readiness: Proven experience with GMP requirements for ATMPs, including ATMP-specific guidelines under EMA and FDA
  • Specialized facilities: Cleanrooms for aseptic processing, viral vector suites, and segregated environments for autologous vs. allogeneic therapies
  • Scalability: Capacity to support your transition from preclinical batches to commercial manufacturing
  • QC and analytics: Advanced characterization tools for potency, purity, and safety of cell- and gene-based therapies
  • Tech transfer expertise: Seamless integration from academic, R&D, or early-phase platforms into GMP operations

Choosing the right partner early can prevent costly delays and compliance risks down the road.

Key Services Offered by Advanced Therapies Contract Manufacturers

Top advanced therapies contract manufacturing providers offer end-to-end support tailored to the needs of ATMPs, including:

  • Process development for viral vectors, stem cells, and genetically modified cells
  • GMP manufacturing for Phase I through commercial scale
  • Viral vector production (lentivirus, AAV, adenovirus, retrovirus)
  • Cell therapy services, including expansion, transduction, and cryopreservation
  • Fill & finish services under aseptic conditions
  • Analytical method development and validation for potency and identity testing
  • Cold chain logistics and controlled distribution

These services are critical for ATMPs where the product is often living, highly sensitive, and patient-specific.

Advantages of Partnering with ATMP CDMO Companies

Collaborating with experienced ATMP CDMO companies brings major advantages:

  • Reduced risk: ATMP-experienced CDMOs anticipate complex regulatory and scientific hurdles
  • Faster timelines: Integrated development and GMP readiness speed up IND/IMPD submissions
  • Tailored infrastructure: Facilities and processes are purpose-built for high-complexity therapies
  • Compliance assurance: These CDMOs have passed rigorous inspections specific to advanced therapies
  • Focus on innovation: Your internal teams can concentrate on R&D while the CDMO handles scale-up and manufacturing

The right Advanced Therapies CDMO doesn’t just produce your therapy — they become a core part of your development strategy.

ATMP CDMO Companies

Some of the leading ATMP CDMO companies in the global market include:

  • VIVEbiotech: Leading GMP-certified CDMO exclusively dedicated to the production of lentiviral vectors. [See CDMO profile]
  • Histocell: ATMP CDMO that develops and manufactures cell therapies from iPSCs, MSCs, secretomes, exosomes and other types of cells, as well as medical devices and dermocosmetics. [See CDMO profile]

These companies are equipped to meet the strict demands of ATMP development while supporting rapid growth and innovation.

Related Information

Let MAI CDMO Network Help You Find the Right ATMP CDMO Partner

At MAI CDMO Network, we help you navigate the complex world of ATMP CDMO companies. Whether you need viral vector development, clinical cell therapy manufacturing, or support scaling a commercial gene therapy, we connect you with the most qualified advanced therapies contract manufacturing experts worldwide.

Ready to accelerate your ATMP development? Contact us today to find a CDMO that matches your therapy, timeline, and regulatory strategy.

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