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Biologics

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Plants in:

India

Established in: 1989

Production scale:

large

Employees: 5000+

6 production facilities approved by USFDA, AGES-Austria, PMDA, WHO

R&D Centers with capabilities of ANDAs, DMFs and NDDS

462+ patents filed for drug substances and polymorphs

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

  • fda

Replies quickly

Located in:

United States

CDMO-CMO


Plants in:

United States

Production scale:

large

Leading in aerosol and transdermal drug delivery systems.

Expertise in both small molecule and biologic drug formulation.

Strong track record in bringing complex therapies to market.

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

Replies slower than most

Plants in:

Germany

Established in: 1980

Production scale:

medium

Employees: 30+

EU-GMP and DIN EN ISO 9001:2015

Pioneer in the fractionation of sheep plasma

Pure & sterile high-quality products

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

Replies quickly

Plants in:

United States

Established in: 2016

Production scale:

medium

small

Low Volume high value API Fill and Finish Service

In-line monitoring, SKAN Isolators, Highly Experienced Staff

Capacity Available, Ready for your API

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

Replies quickly

Plants in:

India

Established in: 1998

Production scale:

small

medium

large

Employees: 1000

Facilities with global regulatory compliance

Customized and Flexible Collaboration Models

End-to-end drug discovery

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

  • fda

  • ema

Replies quickly

Located in:

United States

Plants in:

United States

Established in: 2020

Production scale:

medium

Specialized in gene therapy and viral vector production.

Expertise in both clinical and commercial scale manufacturing.

Focus on quality, safety, and regulatory excellence in biologics.

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

Replies slower than most

CDMO-CMO


Plants in:

India

Established in: 2021

Production scale:

small

Employees: 19

API, Intermediates, Building Blocks, Impurities, Amino acids and Peptides

Small quantity APIs to commercial scale

GMP and USFDA certification based on quantity, order, assignment.

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

  • fda

Replies quickly

CDMO-CMO


Plants in:

United States

Established in: 2018

Production scale:

large

Successfully inspected by TGA, PMDA, MHRA, ANVISA, Health Canada, MPA, IMB, & FDA

All facilities are in good standing with all regulatory authorities, including DEA, EPA, OSHA

Quality Management System and supporting analytical processes are almost 100% electronic

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

Replies quickly

Located in:

China

Plants in:

China

Production scale:

small

medium

large

Established for 17 years and a leading enterprise in China's API industry

Mature technology and advanced production equipment

Quality assurance and fast delivery

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

Replies quickly

Located in:

United States

CDMO-CMO


Plants in:

United States

Established in: 2020

Production scale:

medium

Innovative approach to biomanufacturing and complex biologics.

Cutting-edge technology for next-generation therapies.

Strong focus on accelerating the development of transformative medicines.

  • GMP

  • FDA

  • EMA

All certificates

    Replies slower than most

    Located in:

    Germany

    Plants in:

    Germany

    Established in: 1885

    Production scale:

    large

    Strong heritage in pharmaceutical innovation and biotechnology.

    Comprehensive range of services from early development to commercial supply.

    Focus on quality, reliability, and sustainability in biopharmaceutical manufacturing.

    • GMP

    • FDA

    • EMA

    All certificates

    • gmp

    Replies slower than most

    Located in:

    United States

    CDMO-CMO


    Plants in:

    United States

    Established in: 1933

    Production scale:

    large

    Pioneering in advanced delivery technologies and development solutions.

    Extensive global network ensuring supply chain resilience.

    Tailored services across biologics, gene therapies, and pharmaceuticals.

    • GMP

    • FDA

    • EMA

    All certificates

    • gmp

    Replies slower than most

    Located in:

    United States

    Plants in:

    United States

    Established in: 1881

    Production scale:

    large

    Noted for excellence in blood products and biologics.

    Committed to safety, quality, and regulatory compliance in healthcare.

    Pioneering in research and development of blood-derived therapeutics.

    • GMP

    • FDA

    • EMA

    All certificates

    • gmp

    Replies slower than most

    Plants in:

    China

    Established in: 2013

    Production scale:

    medium

    Employees: 25+

    ISO9001 certified

    Drug R&D center (in Hangzhou)

    From lab scale (mg/g) to commercial scale (kgs/tons)

    • GMP

    • FDA

    • EMA

    All certificates

    • gmp

    Replies quickly

    Located in:

    Germany

    CDMO-CMO


    Plants in:

    Germany

    Established in: 2009

    Production scale:

    large

    Specialized in enzyme-based products and custom biocatalysis solutions.

    Strong focus on sustainability and green chemistry in pharmaceutical manufacturing.

    Innovative R&D for novel enzyme applications and process optimization.

    • GMP

    • FDA

    • EMA

    All certificates

      Replies slower than most

      Located in:

      United States

      Plants in:

      United States

      Established in: 2002

      Production scale:

      large

      Specialized in biologics CDMO services with a focus on monoclonal antibodies.

      Advanced facilities for clinical and commercial-scale manufacturing.

      Strong commitment to quality and regulatory compliance.

      • GMP

      • FDA

      • EMA

      All certificates

      • gmp

      • fda

      Replies slower than most

      Located in:

      Norway

      CDMO-CMO


      Plants in:

      Norway

      Established in: 2007

      Production scale:

      small

      large

      Specialized in liquid and semi-solid pharmaceuticals manufacturing.

      Nordic excellence in quality and reliability.

      Flexible production capabilities catering to a wide range of batch sizes.

      • GMP

      • FDA

      • EMA

      All certificates

      • gmp

      Replies slower than most

      Located in:

      United States

      Plants in:

      United States

      Production scale:

      large

      Expertise in cell therapy development and manufacturing.

      Tailored solutions for autologous and allogeneic cell therapies.

      Cutting-edge technology for scalable and efficient cell therapy production.

      • GMP

      • FDA

      • EMA

      All certificates

      • gmp

      Replies slower than most

      Located in:

      United States

      Plants in:

      United States

      Established in: 1996

      Production scale:

      large

      small

      medium

      Leading in biopharmaceutical development and biologic API production.

      Comprehensive services from cell line development to commercial manufacturing.

      Strong track record in delivering complex and high-quality biologics.

      • GMP

      • FDA

      • EMA

      All certificates

      • gmp

      • ema

      • fda

      Looking for CMO/CDMO Services?

      Find a list of providers specializing in CMOs/CDMOs Services for Biologics. Navigate through our extensive selection to identify the supplier that aligns with your specific needs.

      Pharmaoffer makes it easy and convenient to send inquiries at no cost. Directly connect with your chosen supplier and take the first step towards fulfilling your pharmaceutical needs easily and efficiently.

      CMO/CDMO - Contract (Development) Manufacturing Organizations

      CDMOs and CMOs are pivotal in the pharmaceutical and biotech industries, offering specialized services in drug development and manufacturing. They assist in scaling up production from laboratory to commercial quantities, while adhering to strict regulatory standards. These organizations play a crucial role in the efficient and cost-effective production of medical and pharmaceutical products, ensuring quality and compliance at every stage.

      Biologics

      Biologics CMOs/CDMOs specialize in the manufacturing and development of biopharmaceutical products, which are typically derived from living organisms or biological sources such as proteins, antibodies, vaccines, and cell therapies. 


      Biologics Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) encompass specialists in the production and development of biopharmaceuticals. These products, often derived from living organisms or biological sources, include proteins, antibodies, vaccines, and cell therapies. This sector includes biologics manufacturers, biopharma CDMOs, and companies dedicated to biologics development and biologic drug manufacturing.


      Key Services Provided by Our Listed Biologics CMOs/CDMOs:


      • Advanced Biopharmaceutical Manufacturing: Utilization of cutting-edge biomanufacturing processes for the production of biologics, ensuring high purity, efficacy, and safety. This includes comprehensive biologics manufacturing and contract manufacturing biologics services.

      • Custom Antibody and Protein Development: Expertise in developing a range of biologic products, including monoclonal antibodies and therapeutic proteins, tailored to specific therapeutic needs. This is a key focus for many biologics companies and CDMO biotech firms.

      • Vaccine Production: Specialization in the manufacturing of vaccines using advanced technologies, contributing to global health and disease prevention efforts. This is a critical service offered by CMO biologics and biologics CDMO list members.

      • Cell Therapy Development: Capability to develop and manufacture innovative cell therapies, offering new treatment possibilities in regenerative medicine and oncology. This is a rapidly growing area within biologics development.

      • Regulatory Expertise: In-depth knowledge of the regulatory environment governing biologics, ensuring compliance with standards set by agencies like the FDA and EMA. This expertise is vital for all aspects of biopharmaceutical manufacturing.


      Your Partner in Biologics Development and Manufacturing

      Pharmaoffer provides a platform to connect with CMOs/CDMOs specializing in biologics. Our category ensures easy access to organizations that are equipped with the expertise and technology required for the complex development and manufacturing processes of biopharmaceutical products.