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CDMO Directory
Directory for Contract Manufacturing

Find the Best Partners with Our Comprehensive CDMO Directory

Showing 218 facilities
Ophtapharm AG
Switzerland

Ophtapharm AG

Ophtapharm, a Sentiss Company

MARKETS: EMA (EU), FDA (USA), Russian Health Authorities, MFDS (South Korea)

COMPLIANCE: FDA (cGMP), EMA (EU GMP)

USE: Human, Veterinary

BATCH SIZE: Large, Small, Medium

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

REGION: Europe

HIPRA BIOTECH SERVICES | Aiguaviva
Spain

HIPRA BIOTECH SERVICES | Aiguaviva

HIPRA Biotech Services

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

SERVICES: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services

MARKETS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia)

COMPLIANCE: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)

BSL (Biological Safety Level): 1, 2

USE: Human

BATCH SIZE: Large, Small, Medium

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)

REGION: Europe

CATEGORY / PRODUCT: BIOLOGICS

Adare Pharma | EU
Italy

Adare Pharma | EU

Adare Pharma Solutions

Global CDMO offering turnkey product development through commercial manufacturing expertise, focused on oral dosage forms.

SERVICES: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), TGA (Australia)

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, French Service-Public (CIR), NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

USE: Human, Veterinary

BATCH SIZE: Large, Small, Medium

THERAPEUTIC AREAS OF EXPERTISE (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (V01) Allergens, (R) Respiratory system, (M) Musculoskeletal system, (C) Cardiovascular system, (A) Digestive tract and metabolism

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING, SERVICES

REGION: Europe

CZ Vaccines | Large Scale Plant Portugal
Portugal

CZ Vaccines | Large Scale Plant Portugal

CZ Vaccines

Commercial Scale Facility

SERVICES: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services

MARKETS: EMA (EU)

COMPLIANCE: ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)

BSL (Biological Safety Level): 1, 2

USE: Human

BATCH SIZE: Large, Medium

THERAPEUTIC AREAS OF EXPERTISE (ATC): (J) Antiinfectives for systemic use, (R) Respiratory system, (G) Genito urinary system and sex hormones

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, BIOLOGICS

REGION: Europe

FEPTest
Hungary

FEPTest

Kromat Ltd. Feptest GMP Lab

SERVICES: Development services, Analytical / QC services

USE: Human

MARKETS: Rest of World

BATCH SIZE: Medium

CATEGORY / PRODUCT: SERVICES

REGION: Europe

HISTOCELL S.L. | Cell Therapy, Exosomes & Secretomes
Spain

HISTOCELL S.L. | Cell Therapy, Exosomes & Secretomes

HISTOCELL

Histocell is a Spanish CDMO that develops and manufactures cell therapies, secretomes and exosomes, as well medical devices.

SERVICES: Development services, Analytical / QC services, Quality Assurance services, Manufacturing services

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), CDSCO (India), TGA (Australia)

COMPLIANCE: ISO, EMA (EU GMP)

BSL (Biological Safety Level): 1, 2

CATEGORY / PRODUCT: COSMETICS, FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS

USE: Human, Veterinary

THERAPEUTIC AREAS OF EXPERTISE (ATC): (N) Nervous system, (D) Dermatologicals, (B) Blood and blood forming organs, (R) Respiratory system, (M) Musculoskeletal system, (C) Cardiovascular system, (A) Digestive tract and metabolism

BATCH SIZE: Small, Medium

REGION: Europe

Adare Pharma | US
United States

Adare Pharma | US

Adare Pharma Solutions

Adare Pharma es un CDMO global con instalaciones en EE.UU. y la UE, que ofrece desarrollo de productos llave en mano mediante experiencia en fabricación comerci

SERVICES: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), TGA (Australia)

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Halal Research Council, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, French Service-Public (CIR), NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

USE: Human, Veterinary

BATCH SIZE: Large, Small, Medium

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING, SERVICES

THERAPEUTIC AREAS OF EXPERTISE (ATC): (C) Cardiovascular system, (A) Digestive tract and metabolism

REGION: North America

FAES FARMA | DERIO facility
Spain

FAES FARMA | DERIO facility

FAES FARMA

Developer and manufacturer of human medicinal products.

SERVICES: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), EDE (UAE), TGA (Australia)

COMPLIANCE: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), French Service-Public (CIR), NMPA (China GMP), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

USE: Human

BATCH SIZE: Large, Small, Medium

THERAPEUTIC AREAS OF EXPERTISE (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (D) Dermatologicals, (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)

REGION: Europe

Laboratorios Grifols | Murcia Plant
Spain

Laboratorios Grifols | Murcia Plant

Grifols International

Sterile manufacturing solutions (small molecules) in flexible bags.

MARKETS: EMA (EU), FDA (USA), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)

COMPLIANCE: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

USE: Human, Veterinary

BATCH SIZE: Large, Small, Medium

SERVICES: Logistics, Analytical / QC services, Packaging, Quality Assurance services, Manufacturing services

CONTROLLED SUBSTANCES: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse

THERAPEUTIC AREAS OF EXPERTISE (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (C) Cardiovascular system, (A) Digestive tract and metabolism

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

REGION: Europe

Cenexi
France

Cenexi

Cenexi

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

SERVICES: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), EDE (UAE), TGA (Australia)

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), NMPA (China GMP), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)

USE: Human, Veterinary

BATCH SIZE: Large, Small, Medium

CONTROLLED SUBSTANCES: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Low potential for abuse

THERAPEUTIC AREAS OF EXPERTISE (ATC): (N) Nervous system, (J) Antiinfectives for systemic use, (D) Dermatologicals, (P) Antiparasitic products, insecticides and repellents, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (C) Cardiovascular system, (A) Digestive tract and metabolism

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)

REGION: Europe

Adragos Pharma | Kawagoe
Japan

Adragos Pharma | Kawagoe

Adragos Pharma

Our facility provides best-in-class manufacturing of tablets and ampoules.

MARKETS: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE), CDSCO (India), TGA (Australia)

COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), EMA (EU GMP)

USE: Human

BATCH SIZE: Large

SERVICES: Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services

CONTROLLED SUBSTANCES: Lowest potential for abuse, Lower potential for abuse, High potential for abuse & medical use, Low potential for abuse

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES

REGION: APAC

Nexora Cell and Tissue Therapy Manufacturing Site
Germany

Nexora Cell and Tissue Therapy Manufacturing Site

Green Phoenix Labs GmbH

Licensed ATMP site in Germany. GMP manufacturing and QP batch release for cell and tissue therapies.

SERVICES: Development services, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services

MARKETS: EMA (EU)

BSL (Biological Safety Level): 1, 2

USE: Human

CONTROLLED SUBSTANCES: Lowest potential for abuse, Lower potential for abuse, Low potential for abuse

THERAPEUTIC AREAS OF EXPERTISE (ATC): (S) Sensory organs, (N) Nervous system, (D) Dermatologicals, (B) Blood and blood forming organs, (R) Respiratory system, (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism

BATCH SIZE: Small, Medium

OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)

COMPLIANCE: EMA (EU GMP)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS

REGION: Europe

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In the dynamic landscape of pharmaceutical contract development and manufacturing, partnering with the right Contract Development and Manufacturing Organization (CDMO) is crucial for success. A comprehensive CDMO directory serves as an invaluable resource, guiding pharmaceutical companies to find partners that align with their specific needs and objectives.

Understanding CDMOs and Their Importance

CDMOs specialize in providing comprehensive services ranging from drug development to manufacturing, enabling pharmaceutical companies to focus on core competencies such as research and marketing. By outsourcing these critical processes, companies can accelerate time-to-market, optimize resources, and maintain flexibility in production scaling.

The Role of a CDMO Directory

A well-curated CDMO directory simplifies the process of identifying and connecting with suitable partners. It offers detailed profiles of various organizations, highlighting their capabilities, areas of expertise, and compliance standards. This transparency allows pharmaceutical companies to make informed decisions, ensuring that their chosen CDMO can meet regulatory requirements and project demands.

Key Features of an Effective CDMO Directory

Offering broad coverage through Comprehensive Listings: An extensive database that includes CDMOs from various regions and specialties ensures that companies can find partners that meet their specific criteria.

Evaluating provider capabilities via Detailed Profiles: Information on each CDMO's services, technological capabilities, certifications, and past projects provides a clear understanding of their expertise.

Targeting specific parameters with Search and Filter Options: Advanced search functionalities allow users to filter CDMOs based on parameters such as location, service offerings, and compliance with specific regulatory bodies.

Verifying performance history through User Reviews and Ratings: Incorporating feedback from previous clients offers insights into the CDMO's reliability, quality of service, and adherence to timelines.

Ensuring current industry accuracy via Up-to-Date Information: Regular updates ensure that the directory reflects the current status of each CDMO, including any new certifications, expansions, or changes in services.

Benefits of Using a CDMO Directory

Accelerating partner selection through Efficiency: Streamlines the partner selection process by providing all necessary information in one place.

Verifying compliance standards for Risk Mitigation: Access to compliance and certification details helps in selecting CDMOs that meet regulatory standards, reducing the risk of non-compliance.

Optimizing budget allocation by remaining Cost-Effective: By identifying CDMOs that offer competitive pricing and services tailored to specific needs, companies can optimize their budgets.

Fostering industry collaboration with Networking Opportunities: Facilitates connections within the industry, potentially leading to collaborations beyond manufacturing, such as research partnerships.

MAI CDMO's CDMO Directory Bridges the Gap in Pharmaceutical Outsourcing

One notable platform in this space is MAI CDMO, a software development company dedicated to fostering a collaborative ecosystem within the pharmaceutical industry. By bridging the gap between pharmaceutical companies and CMO/CDMOs, MAI CDMO ensures optimal resource allocation throughout the development process. This collaborative approach empowers partners to achieve their goals with greater efficiency and focus on innovation.

Navigating the CDMO Landscape

The pharmaceutical industry is continually evolving, with new technologies and methodologies emerging regularly. A reliable CDMO directory keeps pace with these changes, offering updated information on CDMOs that adopt innovative approaches, such as continuous manufacturing, single-use technologies, and advanced analytics.

Global Reach and Local Expertise

While global CDMOs offer extensive resources and capabilities, regional CDMOs provide local expertise and a better understanding of specific market dynamics. A comprehensive CDMO directory includes both, allowing companies to choose partners that best fit their strategic goals, whether it's entering a new market or leveraging specialized local knowledge.

Ensuring Quality and Compliance

Quality assurance is paramount in pharmaceutical manufacturing. A CDMO directory that provides information on quality metrics, inspection histories, and compliance records enables companies to select partners committed to maintaining high standards. This focus on quality not only ensures patient safety but also protects the company's reputation.

Future Trends in CDMO Partnerships

As the pharmaceutical industry embraces personalized medicine, biologics, and gene therapies, the role of CDMOs is expanding. Directories that highlight CDMOs with capabilities in these cutting-edge areas become essential tools for companies looking to innovate and stay competitive.

Conclusion

A quality CDMO directory is more than just a list; it's a strategic resource that empowers pharmaceutical companies to find the right partners efficiently. By providing detailed, up-to-date information, such directories facilitate collaborations that drive innovation, ensure compliance, and ultimately lead to the successful development and delivery of life-saving therapies.

Leveraging a platform like MAI CDMO can significantly enhance the outsourcing process, fostering a collaborative environment that benefits all stakeholders in the pharmaceutical industry. As the landscape continues to evolve, these directories will play a pivotal role in shaping the future of pharmaceutical development and manufacturing.