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

Find Drug Substances that produce:
Small Molecule APIs

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

All certificates

  • gmp

  • 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

  • ema

  • gmp

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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

  • EMA

All certificates

  • 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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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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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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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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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

  • gmp

Replies quickly

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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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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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

    Replies quickly

    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

    • gmp

    • fda

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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

    • FDA

    • EMA

    All certificates

    • gmp

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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

    All certificates

    • fda

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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

    • gmp

    • fda

    Replies quickly

    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:

    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

    • gmp

    • fda

    • ema

    Replies quickly

    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

    • gmp

    • fda

    • ema

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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:

    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:

    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

    Looking for Drug Substance Services?

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

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    Drug Substance (CDMO/CRO)

    Drug Substance CDMOs and CROs provide end-to-end solutions for pharmaceutical companies developing and manufacturing active pharmaceutical ingredients (APIs). These organizations offer critical support in R&D, process development, scale-up, and GMP manufacturing, enabling pharma and biotech companies to accelerate time-to-market while ensuring compliance with global regulatory standards.

    Small Molecule APIs

    Small molecule APIs are chemically synthesized compounds with low molecular weight, commonly used in pharmaceuticals. They offer predictable pharmacokinetics and are cost-effective to produce at scale.