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CDMO Directory
Directory for Contract Manufacturing

Find the Best Partners with Our Comprehensive CDMO Directory

Showing 216 facilities
CARBOGEN AMCIS | Bubendorf
Switzerland

CARBOGEN AMCIS | Bubendorf

CARBOGEN AMCIS

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

SERVICES: Development services, Analytical / QC services, 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), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), Turkish Health Authorities, CDSCO (India), TGA (Australia)

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU GMP), World Health Organization (GMP / HACCP)

USE: Human, Veterinary

THERAPEUTIC AREAS OF EXPERTISE (ATC): (V09-10) Radiopharmaceuticals, (N) Nervous system, (D) Dermatologicals, (B) Blood and blood forming organs, (R) Respiratory system, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (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), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day)

CATEGORY / PRODUCT: PARTICLE ENGINEERING, SERVICES, BIOLOGICS, CHEMICAL-SYNTHETIC

REGION: Europe

HIPRA BIOTECH SERVICES | Amer
Spain

HIPRA BIOTECH SERVICES | Amer

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, 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), 2 (PDE = 1,000 - 10,000 µg/day)

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, BIOLOGICS

REGION: Europe

JAFRAL
Slovenia

JAFRAL

JAFRAL

Integrated biotechnology facility providing R&D, non-GMP and GMP manufacturing, QC testing, and fill & finish services for advanced biologics.

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

COMPLIANCE: ICH, FDA (cGMP), ISO, EMA (EU GMP), World Health Organization (GMP / HACCP), SQF (Safe Quality Food)

MARKETS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia)

BSL (Biological Safety Level): 1, 2

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

USE: Human, Veterinary

BATCH SIZE: Large, Small, Medium

CONTROLLED SUBSTANCES: Lowest potential for abuse

THERAPEUTIC AREAS OF EXPERTISE (ATC): (J) Antiinfectives for systemic use, (D) Dermatologicals, (V06) Nutrients, (R) Respiratory system, (A) Digestive tract and metabolism

REGION: Europe

Bilthoven Biologicals Drug Substance and Drug Product Facilities
Netherlands

Bilthoven Biologicals Drug Substance and Drug Product Facilities

Bilthoven Biologicals BV

Multi-product GMP facilities for Drug Substance and Drug Product.

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

MARKETS: EMA (EU), MHRA (UK)

BSL (Biological Safety Level): 1, 2

USE: Human

BATCH SIZE: Large, Small, Medium

COMPLIANCE: EMA (EU GMP)

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

REGION: Europe

HBM Pharma
Slovakia

HBM Pharma

Hbm Pharma

EU-GMP-certified CMO based in Martin, Slovakia. The company provides manufacturing and packaging servicesfor sterile pharm. products and solid oral dosage forms

MARKETS: EMA (EU), NMPA (China), Health Canada (Canada), ANVISA (Brazil), COFEPRIS (Mexico), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, TGA (Australia)

COMPLIANCE: ISO, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), ANVISA (Brazil)

USE: Human

BATCH SIZE: Large, Small, Medium

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

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)

CONTROLLED SUBSTANCES: High potential for abuse & medical use

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS, SERVICES

REGION: Europe

SENN Chemicals | R&D and Kilo Lab | Dielsdorf, Switzerland
Switzerland

SENN Chemicals | R&D and Kilo Lab | Dielsdorf, Switzerland

Senn Chemicals

Swiss peptide and peptide intermediates R&D site with SPPS, LPPS, hybrid synthesis, kilo lab scale up, purification and analytics.

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

REGION: Europe

CATEGORY / PRODUCT: COSMETICS, CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING

BATCH SIZE: Small

SENN Chemicals | Small Scale GMP Lab | Dielsdorf, Switzerland
Switzerland

SENN Chemicals | Small Scale GMP Lab | Dielsdorf, Switzerland

Senn Chemicals

Small scale GMP peptide and organic synthesis lab for clinical, niche and high value projects requiring flexible cGMP production.

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

REGION: Europe

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, PARTICLE ENGINEERING

BATCH SIZE: Small

SENN Chemicals | GMP Production | Dielsdorf, Switzerland
Switzerland

SENN Chemicals | GMP Production | Dielsdorf, Switzerland

Senn Chemicals

Swiss cGMP production site for LPPS, SPPS and hybrid peptide manufacturing from pilot to early commercial scale.

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

REGION: Europe

BATCH SIZE: Large, Medium

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, PARTICLE ENGINEERING

SENN India | Non-GMP Plant | Hyderabad, India
India

SENN India | Non-GMP Plant | Hyderabad, India

Senn Chemicals

Large scale non GMP manufacturing site for peptide intermediates, organic synthesis, LPPS operations and scale up production.

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

REGION: APAC

BATCH SIZE: Large, Small, Medium

CATEGORY / PRODUCT: COSMETICS, CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING

SENN India | R&D Lab | Hyderabad, India
India

SENN India | R&D Lab | Hyderabad, India

Senn Chemicals

R&D centre for peptide and organic chemistry with SPPS, purification, lyophilisation, analytics and particle engineering support.

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

REGION: APAC

CATEGORY / PRODUCT: CHEMICAL-SYNTHETIC, PARTICLE ENGINEERING

BATCH SIZE: Small

Laboratorio REIG JOFRE, SA (TOLEDO PLANT)
Spain

Laboratorio REIG JOFRE, SA (TOLEDO PLANT)

LABORATORIO REIG JOFRE SA

Betalactam antibiotics (FDF) development and manufacturing state-of-the-art facilities.

MARKETS: EMA (EU), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), INVIMA (Colombia), SFDA (Saudi Arabia), TGA (Australia)

REGION: APAC, MENA, LATAM, Europe, North America

COMPLIANCE: DIGEMID, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)

BATCH SIZE: Large, Medium

USE: Human, Veterinary

BSL (Biological Safety Level): 1

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

THERAPEUTIC AREAS OF EXPERTISE (ATC): (J) Antiinfectives for systemic use

CONTROLLED SUBSTANCES: Lowest potential for abuse

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

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

Laboratorios Grifols | Barcelona Plant
Spain

Laboratorios Grifols | Barcelona Plant

Grifols International

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

MARKETS: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)

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

REGION: Europe

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)

BATCH SIZE: Large, Small, Medium

USE: Human, Veterinary

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

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

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

CATEGORY / PRODUCT: FDF / DRUG PRODUCTS

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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.