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

Find and compare companies providing:
Contract pharmaceutical outsourcing services


Filter by expertise, certification, scale and geography to shortlist trusted contract pharmaceutical service providers for effective pharma outsourcing.

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

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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

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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

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HIGHLIGHTED

Located in:

Germany

Plants in:

Germany

Established in: 1886

Production scale:

medium

small

Employees: 275+

Raw materials, CMO and OTC products

Two GMP certified locations

Customisable (small-sized) packages

  • GMP

  • FDA

  • EMA

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HIGHLIGHTED

Located in:

United States

Plants in:

United States

Established in: 1975

Production scale:

small

medium

large

Employees: 234

45+ years of experience in oral solid and nonsterile oral liquid

Specialization in pediatric, geriatric, and controlled-substance

Reliable and flexible full-service production partner

  • GMP

  • FDA

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All certificates

  • fda

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HIGHLIGHTED

Located in:

India

Plants in:

India

Established in: 2023

Production scale:

small

medium

large

Employees: 1000+

Expertise in Conventional, Complex, and Niche Chemistries

End-to-end Support from early development to Commercial Phases

Comprehensive Analytical Support Facilities

  • GMP

  • FDA

  • EMA

All certificates

  • fda

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HIGHLIGHTED

Located in:

Poland

Plants in:

Poland

Production scale:

small

medium

large

  • GMP

  • FDA

  • EMA

All certificates

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Plants in:

ItalyPortugal

Established in: 1993

Production scale:

small

medium

large

Employees: 600

Integrated innovative platforms for Technology Transfer (TT&GO®)

Fermentation, purification, and chemical synthesis technologies on the same site

Scalability from Laboratory and Pilot to Industrial scales

  • GMP

  • FDA

  • EMA

All certificates

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Plants in:

China

Established in: 2008

Production scale:

large

medium

Employees: 300+

More than 150 patents based on independent intelligence

Expertise in anti-tumor, anti-diabetes and cardiovascular API and intermediates.

GMP facility with annual production capacity of 300M

  • GMP

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Plants in:

Poland

Established in: 1951

Production scale:

medium

Employees: 455+

Largest Polish manufacturer of pharmaceuticals and a leader of the Polish pharmaceutical market.

FDA approved european manufcaturing facilities

Export APIs to more than 60 countries worldwide

  • GMP

  • FDA

  • EMA

All certificates

  • gmp

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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

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Located in:

Denmark

Plants in:

Denmark

Established in: 1965

Production scale:

small

medium

large

Employees: 600+

Pharmaceutical-quality dextrans meeting the highest standards and complying with major pharmacopeias

Manufactured in a cGMP facility in Denmark, inspected by both the FDA and EMA

Documented quality and certifications from the US FDA and EDQM for smooth regulatory submission

  • GMP

  • FDA

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All certificates

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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

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Plants in:

China

Established in: 2019

Production scale:

large

Employees: 10+

Focused on pharmaceutical industry

Reasonable price for the customers

Full service from R&D stage to commercial stage

  • GMP

  • FDA

  • EMA

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Plants in:

China

Established in: 2014

Production scale:

small

medium

large

Employees: 1000+

24 years of production experience

6 workshops and 9 production lines which has 100t/month production capacity

4 USDMFS & 8 CEPS & 200+ Patents

  • GMP

  • FDA

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All certificates

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Located in:

China

Plants in:

China

Established in: 2003

Production scale:

large

Employees: 4000+

20+ years’ expertise in API manufacturing, trusted for quality and global compliance.

Listed pharma leader in China, prioritizing transparency and regulatory excellence.

End-to-end integration from R&D to scalable production, delivering cost-efficient solutions.

  • GMP

  • FDA

  • EMA

All certificates

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Located in:

United States

Plants in:

China

Established in: 2006

Production scale:

small

medium

large

Employees: 3500

Silver EcoVadis awardee committed to sustainability

Exceptional synthesis experience of HPAPIs

One-stop CDMO Solutions for APl and Key intermediates

  • GMP

  • FDA

  • EMA

All certificates

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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

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Plants in:

Latvia

Established in: 1972

Production scale:

medium

Employees: 1,000+

EU-GMP for APIs and CEP for certain APIs

Exporting to over 50 countries worldwide

Long-standing technological advantage in adamantane, quinuclidine and nitrofurane chemistry

  • GMP

  • FDA

  • EMA

All certificates

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Plants in:

AustriaGermany

Established in: 1934

Production scale:

large

small

medium

Employees: 1500

Full-Service CDMO with End-to-End Solutions

Reliable Global Distribution Operating in over 70 countries

Specialized in hormones, crystal-suspensions and complex injectables

  • GMP

  • FDA

  • EMA

All certificates

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Plants in:

Spain

Established in: 1955

Production scale:

small

medium

large

Employees: 500+

BFS expertise with FDA Approval for Sterile Manufacturing

USA and European Quality

Innovative solutions for ophthalmology and otorhinolaryngology

  • GMP

  • FDA

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All certificates

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Located in:

China

Plants in:

China

Established in: 2012

Production scale:

medium

Employees: 180

A high-tech enterprise with 13 own patents granted

Strong R&D system with ISO9001 / ISO14001 / OHSAS18001 certification

Provide professional CMO & CDMO service

  • GMP

  • FDA

  • EMA

All certificates

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    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

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      Plants in:

      Switzerland

      Established in: 1964

      Production scale:

      small

      medium

      large

      Employees: 135+

      Market leader in Switzerland

      Small and medium batch sizes

      Pharmaceutical raw materials with a herbal or synthetic basis

      • GMP

      • FDA

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      Located in:

      United States

      Plants in:

      United States

      Established in: 2010

      Employees: 185

      15 years of experience in synthetic chemistry, PhD & Master up to 50 employees

      Logistics advantage: global customers can be delivered within 2-7 working days

      Confidentiality Assured: With confidentiality clauses to ensure customer data security

      • GMP

      • FDA

      • EMA

      All certificates

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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

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        Plants in:

        FranceBelgium

        Established in: 1952

        Production scale:

        small

        medium

        large

        Employees: 550+

        API manufacturing (Innovators, Generics and Highly Potent)

        A tailor-made and flexible service approach

        State-of-the-art analytical services including solid form and QbD laboratories

        • GMP

        • FDA

        • EMA

        All certificates

        • gmp

        • fda

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        Plants in:

        China

        Established in: 1987

        Production scale:

        medium

        small

        large

        Employees: 50+

        ISO 9001:2015 & SGS audited supplier

        One-stop CDMO Solutions for APl and Key intermediates

        Specialized in APIs & Pharmaceutical Intermediates for 38 years

        • GMP

        • FDA

        • EMA

        All certificates

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        Located in:

        India

        Plants in:

        India

        Established in: 2022

        Production scale:

        large

        Employees: 50

        Complex Chemistry Expertise – 30+ advanced chemistries backed by a strong R&D team

        End-to-End Molecule Development from Idea to Commercial Scale

        Global Quality, India Advantage – cGMP/FDA-compliant facilities, world-class SHE & IP standard at effecient pricing

        • GMP

        • FDA

        • EMA

        All certificates

        • gmp

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        Plants in:

        United States

        Established in: 2005

        Production scale:

        medium

        small

        Employees: 200+

        Portfolio of over 2,000 APIs

        Precise quality control

        End-to-end global regulatory support

        • GMP

        • FDA

        • EMA

        All certificates

        • gmp

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        Located in:

        Germany

        Plants in:

        Germany

        Established in: 1982

        Production scale:

        small

        Employees: 30+

        Modern GMP facility

        Team of academics and technical experts

        Small to large batch sizes possible

        • GMP

        • FDA

        • EMA

        All certificates

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        Located in:

        China

        Plants in:

        China

        Established in: 2016

        Production scale:

        small

        medium

        large

        Employees: 200

        PFAS-Free Peptides

        Certified Quality & Sustainability with ISO 9000 certification and RSPO audited supplier & GMP

        Specialized in APIs & Pharmaceutical Intermediates

        • GMP

        • FDA

        • EMA

        All certificates

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        Located in:

        United Kingdom

        Plants in:

        United Kingdom

        Established in: 2006

        Production scale:

        small

        medium

        Employees: 20

        Quality Assurance: Products are manufactured from the finest raw materials and undergo rigorous testing.

        Tailored Customisation & Compliance: Providing end-to-end solutions to meet your business

        Dependable Expertise and Supply: Backed by years of industry experience and a robust supply chain.

        • GMP

        • FDA

        • EMA

        All certificates

        • gmp

        Replies quickly

        Located in:

        Germany

        Plants in:

        Germany

        Established in: 1997

        Production scale:

        small

        medium

        Employees: 140

        Top-tier adherence to global pharmaceutical standards including GMP, FDA and EMA

        Specialized advanced chemistry laboratory focused on upscaling and GMP transfer processes

        Comprehensive analytical services to meet precise client specifications.

        • GMP

        • FDA

        • EMA

        All certificates

        • gmp

        • fda

        • ema

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        Located in:

        Singapore

        Plants in:

        Singapore

        Established in: 2011

        Production scale:

        small

        Employees: 50+

        Comprehensive Product Portfolio with Competitive Pricing.

        Focus on Quality and Regulatory Compliance, One-stop, Responsive, End-to-End Service from R&D Through Commercialization.

        Expertise and Reliability in Pharmaceutical Material Supply, Backed by a Singaporean Presence.

        • GMP

        • FDA

        • EMA

        All certificates

        • gmp

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        Located in:

        China

        Plants in:

        China

        Established in: 2016

        Production scale:

        large

        Certified by US FDA

        Well-Established Environmental, Health & Safety Protocols

        Seasoned Project Execution Team

        • GMP

        • FDA

        • EMA

        All certificates

        • gmp

        • fda

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        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

        Plants in:

        United States

        Established in: 1942

        Production scale:

        large

        Over 100 unique marketed pharmaceutical products and 17 approved product applications since 2019

        Manufacturing capacities : 3.5B Oral Solid doses and 2.0M liters of liquids per year

        We specialize in contract manufacturing of Oral Solid Dose (OSD) and Liquids, including high potency substances and small molecules.

        • GMP

        • FDA

        • EMA

        All certificates

          Replies slower than most

          Located in:

          Spain

          Plants in:

          Spain

          Established in: 1940

          Production scale:

          large

          Leading global provider of plasma-derived medicines.

          Strong focus on innovation in bioscience solutions.

          Comprehensive services from plasma collection to finished product.

          • GMP

          • FDA

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          All certificates

            Replies slower than most

            Located in:

            United States

            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

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            All certificates

            • gmp

            Replies slower than most

            Located in:

            United States

            Plants in:

            United States

            Established in: 1928

            Production scale:

            large

            Advanced polymers technology for optimized drug delivery systems.

            Global capabilities in complex formulations and specialty chemicals.

            Emphasis on collaborative partnerships for innovative solutions.

            • GMP

            • FDA

            • EMA

            All certificates

            • gmp

            Replies slower than most

            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

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            All certificates

            • gmp

            Replies slower than most

            Located in:

            Canada

            Plants in:

            Canada

            Established in: 2014

            Specialized in sterile ophthalmic and injectable formulations.

            Focus on flexibility and customization for client-specific needs.

            Advanced manufacturing capabilities in a controlled environment.

            • GMP

            • FDA

            • EMA

            All certificates

            • gmp

            Replies slower than most

            Located in:

            France

            Plants in:

            France

            Established in: 1962

            Production scale:

            large

            500 millions of lozenges per year at the Aignan site

            143 million packs per year at the Gien site

            252 formulations per year at the Cahors site

            • GMP

            • FDA

            • EMA

            All certificates

              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

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              All certificates

              • gmp

              Replies slower than most

              Located in:

              United States

              Plants in:

              United States

              Leaders in dermatological product development and testing.

              Innovative solutions for skin permeation and absorption studies.

              Strong focus on client-centric, scientifically driven services.

              • GMP

              • FDA

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              All certificates

                Replies slower than most

                Located in:

                Norway

                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 Kingdom

                Plants in:

                United Kingdom

                Specialized in sterile and non-sterile pharmaceutical manufacturing.

                Focus on flexibility and customization for client-specific needs.

                State-of-the-art technology ensuring quality and efficiency.

                • GMP

                • FDA

                • EMA

                All certificates

                  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:

                  Italy

                  Plants in:

                  Italy

                  Dedicated to high-quality ophthalmic and ENT product manufacturing.

                  Emphasis on natural and gentle formulations for sensitive applications.

                  Italian excellence in innovative product development and production.

                  • GMP

                  • FDA

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                  All certificates

                    Replies slower than most

                    Located in:

                    Portugal

                    Plants in:

                    Portugal

                    Established in: 2013

                    Production scale:

                    small

                    medium

                    Employees: 50

                    Custom Fermentation Solutions, Strain Selection & Development

                    Process optimization to maximize yield, efficiency, and product quality

                    Support and scale-up expertise with consistent and reliable results each stage

                    • GMP

                    • FDA

                    • EMA

                    All certificates

                      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

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                      All certificates

                      • gmp

                      Replies slower than most

                      Located in:

                      Germany

                      Plants in:

                      Germany

                      Established in: 1950

                      Excellence in aseptic filling and packaging solutions for biologics.

                      Customized solutions for pre-filled syringes, vials, and cartridges.

                      Strong track record in supporting global market launches.

                      • GMP

                      • FDA

                      • EMA

                      All certificates

                        Replies slower than most

                        Located in:

                        United States

                        Plants in:

                        United States

                        Established in: 1995

                        Innovator in blow-fill-seal technology for sterile liquid dosages.

                        Expertise in unit dose packaging for ophthalmics and respiratory solutions.

                        State-of-the-art facilities ensuring precision and scalability.

                        • GMP

                        • FDA

                        • EMA

                        All certificates

                          Replies slower than most

                          Located in:

                          China

                          Plants in:

                          China

                          Established in: 2023

                          Production scale:

                          medium

                          Employees: 34

                          Ensures stability across batches from gene editing to enzyme and UDCA production

                          GMP standards compliance to ensure the lowest levels of single, total, and C impurities within the product category

                          Customized services, supplying enzymes for UDCA conversion and crude UDCA products with purity from 85% to 99.99%

                          • GMP

                          • FDA

                          • EMA

                          All certificates

                          • gmp

                          Replies quickly

                          Located in:

                          Italy

                          Plants in:

                          Italy

                          Expertise in ophthalmic drug delivery solutions.

                          Committed to high-quality standards and patient safety.

                          Innovative R&D for advanced ophthalmic formulations.

                          • GMP

                          • FDA

                          • EMA

                          All certificates

                            Replies slower than most

                            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:

                            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

                            What is a CDMO, CMO, and CRO?

                            Outsourcing terms are often used interchangeably, but they describe different scopes. This page is a directory for CDMO services and CMO services, with guidance to help you route correctly.

                            CDMO

                            Development + manufacturing: process development, scale-up, tech transfer, validation, and GMP production.

                            CMO

                            Manufacturing execution: GMP manufacturing, packaging, and supply continuity once the process is established.

                            CRO

                            Research and clinical support: analytical/bioanalytical work, clinical services, and research-heavy deliverables.

                            Practical rule: ignore the label and validate the scope (what’s in-house, what’s routine for them, and what they can support at your stage).

                            How to choose the right outsourcing model

                            Browsing suppliers is the easy part. Choosing the right outsourcing setup is where projects win or stall. Use the sections below to route correctly and approach suppliers with clear requirements.

                            Decision tree: where should you start?

                            This is a practical routing checklist (not a textbook). Use it to avoid contacting the wrong type of supplier.

                            1. What are you outsourcing?
                              Active ingredient / API / upstream manufacturing → start with Drug Substance (CDMO/CRO)
                              Finished dosage form / fill-finish / packaging → start with Drug Product (CMO)

                            2. Do you need development or only manufacturing?
                              Development + manufacturing → shortlist CDMO services
                              Manufacturing only (process already defined) → shortlist CMO services

                            3. Any specialized constraints?
                              Sterile manufacturing, high potency/containment (OEB), cold chain, controlled substances → shortlist specialized facilities first

                            4. Which stage are you in?
                              Early development / clinical → flexibility, small batches, fast iteration
                              Commercial → capacity, quality maturity, supply reliability, documentation readiness

                            How outsourcing typically works

                            A smooth outsourcing project is mostly about clarity and preparation. These steps help you move faster and reduce rework.

                            1. Define requirements (product type, stage, markets, batch sizes, timelines)

                            2. Build a shortlist (capability fit + region + quality requirements)

                            3. Share a concise project brief (and sign an NDA if needed)

                            4. Feasibility & proposal (timeline, costs, risks, required inputs)

                            5. Quality assessment (documentation review, audit readiness)

                            6. Agreement setup (quality agreement, responsibilities, change control)

                            7. Tech transfer (process, analytics, materials, packaging components)

                            8. Validation & routine supply (as required by stage and markets)

                            Supplier evaluation checklist

                            Suppliers respond faster and more accurately when your brief is clear. Use this checklist before outreach.

                            What to prepare before contacting suppliers

                            • Product type (Drug Substance / Drug Product) and dosage form (if applicable)
                            • Development stage (preclinical / clinical / commercial)
                            • Batch sizes and annual demand estimate
                            • Target markets (EU/US/other) and quality expectations (GMP, documentation)
                            • Key constraints (sterile, containment/OEB, cold chain, controlled substances)
                            • Timeline (tech transfer, first batch, launch window)

                            Questions to ask during evaluation

                            • Capability & experience: similar products? similar scales? which steps are in-house?
                            • Quality & compliance: inspections/markets supported, CAPA/change control maturity
                            • Capacity & timelines: realistic lead times, bottlenecks, mitigation plan
                            • Communication: ownership, cadence, escalation, documentation standards
                            RFQ template: what to include in your first message

                            If your first message is vague, quotes will be vague. Include the items below to speed up proposals.

                            • Scope: Drug Substance or Drug Product; development needed or manufacturing only
                            • Stage: clinical vs commercial; target markets (FDA/EMA/others)
                            • Volumes: batch sizes + annual demand estimate
                            • Constraints: sterile, containment/OEB, cold chain, controlled substances
                            • Timeline: desired start date, first batch, launch window
                            • Quality: required certifications, audit expectations, documentation level

                            FAQ: CDMO & CMO outsourcing

                            Quick answers for common sourcing questions. If you’re unsure, use the open inquiry option above and include your constraints.

                            Should I choose a CDMO or a CMO?

                            Choose a CDMO when you need development work (process development, scale-up, tech transfer support) along with manufacturing. Choose a CMO when your process is established and you mainly need manufacturing execution and supply.

                            What is the difference between Drug Substance and Drug Product?

                            Drug Substance is the active ingredient (API). Drug Product is the finished dosage form patients use (tablets, capsules, injectables, sprays, creams, etc.).

                            When should I involve a CRO?

                            Involve a CRO when your scope includes research-heavy work (bioanalysis, clinical services, specialized analytical tasks). Some CDMOs also provide CRO-like services; validate what’s truly in-house.

                            Can one supplier handle both Drug Substance and Drug Product?

                            Sometimes yes, but many suppliers specialize. The fastest approach is usually to shortlist based on the exact stage and manufacturing scope you need now, then expand if you want a single long-term partner.

                            How do I shortlist suppliers quickly without missing a good option?

                            Start with scope (Drug Substance vs Drug Product), then filter by constraints (sterile, containment/OEB), target markets (FDA/EMA), and scale (batch size). Only then compare “nice-to-haves.”

                            What affects price the most in outsourcing quotes?

                            The biggest drivers are development effort, complexity (sterile/containment), batch size, analytical requirements, validation scope, and documentation/market requirements. Clear inputs reduce pricing uncertainty.

                            Do I need an NDA before contacting a CDMO/CMO?

                            Often yes if you need to share sensitive details. Many suppliers can review a high-level brief without an NDA, then sign one before detailed transfer.

                            How do I verify GMP capabilities?

                            Check relevant certifications/inspections for your target markets, ask what’s in-scope at the specific facility, and validate quality systems (deviations/CAPA, change control, batch record/release workflow). Audits are common for final confirmation.

                            How long does it take to onboard a new outsourcing partner?

                            It depends on stage and complexity. Expect time for feasibility, quality assessment, agreements, and tech transfer. Sterile, high potency, or complex biologics typically require longer lead times.

                            What should I include in an open inquiry to get better matches?

                            Include product type (Drug Substance/Drug Product), stage, markets, batch sizes, key constraints (sterile/OEB/cold chain), and timeline. The more specific you are, the fewer irrelevant matches you get.