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Otic CDMO Companies | Otic Contract Manufacturing Services

Your Trusted Otic CDMO Partners for Otic Products Contract Manufacturing

  
Aenova Group
Germany Europe
Aenova Group Discover our facility

Headquarter - Location Starnberg

  • Activity: N/A manufacturing
  • Uses: N/A
  • Therapeutic areas: N/A
  • Certifications: N/A
  • Services: N/A
  • Batch Size / Reactor: N/A
  • DEA: N/A
  • Toxicity (OEB classification): N/A
  • BSL: N/A
  • Markets: N/A
in Europe
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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
in Europe
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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
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
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: Storage, R&D, Analytical methods development,...
  • 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)
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)
NUTRACEUTICALS in North America
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Spain Europe
OLIGONUCLEOTIDES in Europe 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: 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: 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: Analytical methods development, Primary packaging,...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: N/A
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
  • 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),...
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), ANVISA (Brazil)
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: Analytical methods development, Storage, CMC...
  • 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...
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: 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: 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),...
CARBOGEN AMCIS | Shanghai, 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: Analytical methods development, Batch...
  • 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),...
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),...
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: 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, 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: 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), 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: Analytical methods development, Batch...
  • Batch Size / Reactor: Small, Medium
  • DEA: Schedule II (high potential for abuse / medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 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: Primary packaging, CMC regulatory support, Tech...
  • 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 Shaoxing Site (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),...
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: Analytical methods development, Batch...
  • 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),...
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),...
FDF / DRUG PRODUCTS in Europe
Join to view all
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: 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 Coventry Site (US)
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),...
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),...
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),...
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: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: Schedule II (high potential for abuse / medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: N/A
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...
Cenexi Laboratoires Thissen
Belgium Europe
Cenexi Laboratoires Thissen Discover our facility

This 8,000 m2 plant, with buildings dotted around a site of nearly seven hectares, is located 20 km south of Brussels and has 340 employees*. It specializes in the production of sterile highly potent injectables, mainly against cancer.

  • Activity: Injectables, FDF / DRUG PRODUCTS manufacturing
  • Uses: 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: 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),...
Pharmaron Cramlington Site (UK)
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: 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),...
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: Storage, CMC regulatory support, Upstream, Tech...
  • 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),...
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: 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), NMPA (China),...
CHEMICAL-SYNTHETIC COSMETICS NUTRACEUTICALS SERVICES in Europe
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Netherlands Europe
CHEMICAL-SYNTHETIC SERVICES in Europe 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: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: Schedule I (high potential for abuse / no medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 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: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: Schedule I (high potential for abuse / no medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 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: Tech transfer, Analytical methods development,...
  • Batch Size / Reactor: Small, Medium, Large
  • DEA: Schedule I (high potential for abuse / no medical...
  • Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE =...
  • BSL: 1, 2, 3, 4
  • Markets: FDA (USA), EMA (EU), PMDA (Japan), NMPA (China),...

Otic drug products — including ear drops, sterile solutions, and suspensions — require highly specialized manufacturing conditions to ensure safety, stability, and effectiveness. Whether treating infections, inflammation, or pain, pharmaceutical companies rely on experienced otic CDMO companies to develop and manufacture high-quality products for otic delivery.

From formulation design to GMP sterile filling, working with a partner skilled in otic contract manufacturing ensures regulatory compliance, microbial integrity, and patient comfort — key factors in otic product success.

How to Choose Otic CDMO Companies

When evaluating otic CDMO companies, it’s essential to consider partners with experience in both formulation and sterile production. Key criteria include:

  • Dosage form specialization: Solutions, suspensions, gels, and powders for otic use

  • Sterile and preservative-free manufacturing capabilities

  • Experience with pH-sensitive formulations compatible with the ear canal

  • Viscosity control to optimize residence time in the ear

  • Microbial control and bioburden testing specific to otic applications

  • Regulatory expertise for FDA, EMA, and global otic drug approvals

A qualified CDMO ensures product performance while meeting strict sterility and safety standards.

Key Services Offered by Otic Contract Manufacturers

Professional otic contract manufacturing partners typically offer:

  • Formulation development for otic solutions, suspensions, and combination products

  • Sterile manufacturing using aseptic filling or terminal sterilization

  • Filling in dropper bottles, single-dose vials, or unit-dose systems

  • Stability studies under ICH conditions specific to otic storage environments

  • Microbiological testing: sterility, endotoxin, and preservative effectiveness

  • Particle size control in suspensions for comfort and absorption

  • Regulatory support for IND, ANDA, or NDA submissions

These services ensure quality, sterility, and compliance throughout the product’s lifecycle.

Advantages of Partnering with Otic CDMO Companies

Working with experienced otic CDMO companies offers important benefits:

  • Targeted expertise in ear-specific formulations and delivery formats

  • Reduced development time through ready-to-use platform technologies

  • Improved patient experience with optimized viscosity and tolerability

  • Regulatory efficiency with proven success in otic product submissions

  • Scalable manufacturing for both small-batch clinical and commercial volumes

A specialized CDMO helps bring your otic drug to market with confidence, speed, and quality assurance.

Otic CDMO Companies

Some of the most reputable otic CDMO companies include:

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

  • Cenexi: Injectables manufacturing. [See CDMO profile]

  • Liof Pharma: Aseptic manufacturing and lyophilization of biologics and injectable drugs. [See CDMO profile]

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

  • ASCIL Biopharm: 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. [See CDMO profile]

  • Ophtapharm, a Sentiss company: Ophtalmic and Otic - Solutions, suspensions, emulsions, ointments and gels - FDA Approved facility. [See CDMO profile]

 

Related Information

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Let MAI CDMO Help You Find the Right Otic CDMO Partner

At MAI CDMO, we connect pharmaceutical companies with the most qualified otic CDMO companies for your formulation, manufacturing, and regulatory needs. Whether you´re launching a new ear drop or reformulating an existing otic product, our network of otic contract manufacturing partners ensures sterile, scalable, and compliant solutions.

 

Looking for a trusted otic manufacturing partner? Contact us today and take the next step with confidence.

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