Drug Substance (CDMO/CRO)
Drug Product (CMO)

Find and compare companies providing Drug Product (CMO) services for:
Biologic Products

HIGHLIGHTED

Located in:

India

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

HIGHLIGHTED

Located in:

Germany

Plants in:

Germany

Established in: 2008

Production scale:

large

small

medium

Employees: 4.000

With 14 production sites in Europe and the USA

7 Development Centers of Excellence covering all dosage forms

13 locations with Technology Services on site for seamless Tech Transfer and product Life-Cycle Management

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

  • fda

  • ema

Replies quickly

HIGHLIGHTED

Located in:

United States

Plants in:

GermanyFranceGreeceSwitzerlandNorwayJapan

Production scale:

large

medium

small

Specialized in complex product development and manufacturing.

High-quality standards with a focus on customer-specific needs.

Agile and innovative approach to CDMO services.

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

  • fda

  • ema

Replies quickly

Plants in:

United StatesIndiaFranceGermanyUnited KingdomSpainItaly

Established in: 1991

Production scale:

small

medium

large

Employees: 3,500+

More than 12 GMP manufacturing facilities (EU, US, India)

Portfolio of more than 240 commercial APIs

We are experts in the cGMP production of highly potent compounds

  • GMP

  • FDA

  • EMA

All certificates

    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: 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

    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:

    Belgium

    Plants in:

    Belgium

    Established in: 2018

    Production scale:

    large

    Comprehensive drug development services from molecule to market.

    Expertise in nanomedicine and drug repurposing.

    Tailored project management ensuring efficiency and transparency.

    • GMP

    • FDA

    • EMA

    All certificates

    • gmp

    Replies slower than most

    Located in:

    Germany

    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:

      United States

      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: 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

      Replies quickly

      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

      Looking for Drug Product (CMO) Services?

      Find a list of providers specializing in CMOs/CDMOs Services for Biologic Products. 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.

      Drug Product (CMO)

      Drug Product CMOs (contract pharmaceutical manufacturing) specialize in formulating, manufacturing, and packaging finished dosage forms such as tablets, capsules, injectables, and liquids. These organizations enable pharmaceutical companies to bring safe, effective, and compliant medicines to market by offering GMP-certified production capabilities, scalability, and regulatory support.

      Biologic Products

      What is biologic products outsourcing (CMO)?

      Biologic outsourcing is partnering with a Contract Manufacturing Organization to manufacture protein-based drug products. Typical steps include formulation, low-shear handling, sterile filtration, aseptic filling, inspection, and packaging.

      Key constraints include aggregation control, cold chain requirements, and container compatibility. Biologic CMOs also coordinate specialized analytics and stability programs for sensitive biologic products.

      When to choose a CMO for biologic products

      • You need aseptic fill finish with low-shear handling.
      • Your product requires refrigerated or frozen storage.
      • You need container formats like syringes or pens.

      Common buyer requirements

      • Defined formulation, concentration, and stability requirements.
      • Container format, fill volume, and inspection expectations.
      • Cold chain handling and shipping requirements.

      Drug Product buyer guide (CMO)

      Use this guide to evaluate biologic contract manufacturing services and avoid cold chain gaps.

      How to choose the right Contract Manufacturing Organization for biologic products
      • Handling controls: low-shear processing and temperature control.
      • Fill finish: aseptic filling and container format compatibility.
      • Cold chain: refrigerated or frozen storage and shipping.
      • Analytics: stability and protein aggregation monitoring.
      RFQ template: what to include for biologic products
      • Formulation: concentration, buffer, and excipient profile.
      • Container format: vial, syringe, cartridge, or pen.
      • Temperature: refrigerated or frozen handling requirements.
      • Batch size: clinical and commercial demand.
      • Markets: target regions and regulatory expectations.
      Common pitfalls in biologic outsourcing
      • Cold chain gaps: insufficient storage capacity or monitoring.
      • Container issues: compatibility and leachables concerns.
      • Analytical gaps: mismatched methods for release and stability.
      Validation and regulatory notes for biologic products
      • Process validation: aseptic simulations and fill accuracy.
      • Cleaning validation: critical for shared biologic suites.
      • Regulatory alignment: inspection history for target markets.

      Biologic Products CMO services FAQ

      Answers to common questions about biologic drug product manufacturing and aseptic fill finish.

      What does a biologic products CMO manufacture?

      Biologic CMOs manufacture finished drug products like monoclonal antibodies and recombinant proteins. Services include formulation, sterile filtration, fill finish, and packaging.

      What is biopharmaceutical contract manufacturing for drug product?

      Biopharmaceutical contract manufacturing for drug product focuses on formulation, aseptic processing, and fill finish of biologics. It emphasizes low-shear handling and cold chain controls.

      Do biologic CMOs support aseptic fill finish?

      Yes, most biologic CMOs provide aseptic fill finish into vials, syringes, or cartridges. Confirm container format compatibility early.

      What are common container formats for biologic drug product manufacturing?

      Common formats include vials, prefilled syringes, cartridges, and pens. Format selection often depends on stability and delivery needs.

      How do biologic CMOs manage protein aggregation?

      CMOs control shear, temperature, and formulation buffers to reduce aggregation risk. Stability studies confirm long-term behavior.

      Is cold chain support standard for biologic CMOs?

      Many biologic CMOs offer refrigerated or frozen storage, but not all. Clarify temperature ranges and monitoring systems in your RFQ.

      What batch sizes are typical for biologic CMOs?

      Batch sizes range from clinical lots to commercial campaigns. Provide demand forecasts to match fill line and formulation capacity.

      Do biologic CMOs provide pharmaceutical packaging services?

      Many offer labeling, cartoning, and serialization. Confirm combination product packaging if devices are involved.

      What are common pitfalls in biologic drug product outsourcing?

      Pitfalls include cold chain gaps, container compatibility issues, and analytical method mismatches. Early alignment reduces risk.

      How do I compare pharmaceutical contract manufacturing organizations for biologics?

      Compare aseptic processing history, cold chain capability, analytical support, and regulatory track record. Use this directory to shortlist biologic CMOs.

      Is finished dosage form manufacturing the same as biologic outsourcing?

      Biologic outsourcing is a subset of finished dosage form manufacturing focused on protein-based products. A drug product CMO may support other dosage forms as well.

      Can a pharma CMO services team support tech transfer for biologics?

      Yes. Provide formulation composition, critical quality attributes, and filtration parameters to support a smooth transfer.

      Do biologic CMOs support lyophilization?

      Some do, especially for stability-sensitive biologics. Confirm lyophilizer capacity and cycle development support.

      What should I include in a biologic product RFQ?

      Include container format, fill volume, temperature requirements, batch sizes, and target markets. These inputs help CMOs confirm line fit.