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

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Drug Substance (CDMO/CRO)

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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  • 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:

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

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  • EMA

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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

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HIGHLIGHTED

Located in:

United States

CDMO-CRO


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

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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

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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

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CDMO-CRO


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

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Located in:

United Kingdom

CDMO-CRO


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

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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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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

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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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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

  • EMA

All certificates

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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:

    China

    Established in: 2014

    Production scale:

    small

    medium

    large

    Employees: 1000+

    23 years of production experience

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

    4 USDMFS & 5 CEPS & 200+ Patents

    • 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

    • EMA

    All certificates

    • gmp

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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

    • gmp

    • fda

    • ema

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    CDMO-CRO


    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

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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

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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

      • gmp

      • fda

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      CDMO-CRO


      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

      • gmp

      • fda

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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:

        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

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        Located in:

        India

        CDMO-CRO


        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

        • fda

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        CDMO-CRO


        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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        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

        • gmp

        • fda

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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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        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:

        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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        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

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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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        • EMA

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        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

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        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

        CDMO-CRO


        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:

        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:

        Belgium

        CDMO-CRO


        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:

        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

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        Located in:

        Norway

        CDMO-CRO


        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

        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

        Looking for Drug Substance Services?

        Find a list of providers specializing in Drug Substance (CDMO/CRO). 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 Substance (CDMO/CRO)

        Drug Substance CDMOs and CROs provide essential services in the development and manufacturing of active pharmaceutical ingredients (APIs). These organizations specialize in early-stage research, process development, and GMP-compliant manufacturing of drug substances for clinical and commercial use.


        Pharmaoffer's Drug Substance CDMO/CRO category includes partners with expertise in small molecules, biologics, peptides, and complex chemistry, all operating under strict regulatory compliance. These providers help companies scale from lab to market efficiently and cost-effectively.


        Key Functions of Drug Substance CDMOs/CROs:


        • API Research and Development: Providing early-stage discovery support, custom synthesis, and process optimization to streamline the development of drug substances.

        • Process Scale-Up and Tech Transfer: Transitioning from bench-scale to pilot and commercial scale production with validated methods and reproducibility.

        • GMP Manufacturing: Delivering high-quality API batches in GMP-certified environments, adhering to FDA, EMA, and other international standards.

        • Analytical Services: Offering comprehensive analytical method development and validation to ensure consistent quality and regulatory compliance.

        • Flexible and Specialized Capabilities: From small molecule synthesis to biologic and peptide manufacturing, these partners provide specialized services tailored to product-specific needs.


        Explore Leading API CDMOs and CROs

        Pharmaoffer connects you with trusted CDMOs and CROs for drug substance development. Our platform enables seamless access to specialized service providers equipped to support your API lifecycle from discovery to commercialization.