CDMO Services

CDMO Services

EUROAPI is the global leader in small molecules APIs, and our innovation and R&D capabilities enable us to accelerate our Contract Development Manufacturing Organization activities in complex molecule segments.

Tides

Through Sanofi’s 15 years of experience in the field of oligonucleotides and 45 years in peptides, EUROAPI can provide different classes of Tides using solid phase chemistry.

From its state-of-the-art platform for the development and scale-up of peptides and oligonucleotides at the Hoechst Industrial Park in Frankfurt (Germany), EUROAPI offers customized manufacturing and analytical services as well as a full array of development activities. These range from clinical phase to submission and launch, including regulatory support and commercial supplies.

A pioneer in solid phase synthesis, our Frankfurt site is regularly inspected by the FDA, along with other international and European agencies.

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Prostaglandins

EUROAPI is a leading global supplier of naturally produced prostaglandins, along with versatile biochemicals responsible for fine-tuning a broad range of physiological reactions. With 16 prostaglandin APIs in our portfolio, numerous patented processes and more than 100 clients worldwide, we deliver robust R&D and fully integrated cGMP-compliant manufacturing with a focus on continuous improvement.

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Particle engineering

EUROAPI is an expert in particle engineering. We master two main technologies: micronization (development and commercial scales, inhalables and nanoparticles) and spray drying (development up to large commercial scales).

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Microbial fermentation

Custom microbes at your service. EUROAPI is a global provider of high-quality custom microbial process development and manufacturing for pharmaceutical clients.

From proteins and enzymes to yeasts and actinomycetes, our expertise spans a wide range of GMO and non-GMO microorganisms procured in our 6,000 m³ of fermentation capacity in France and Italy. And we constantly deliver by meeting rigorous pharmaceutical, environmental, health and safety standards.

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Small molecules synthesis

EUROAPI can leverage its remarkable history in API development and organic synthesis by combining the collective chemical expertise of Hoechst-Aventis, Roussel-Uclaf, Chinoin, Genzyme and Sanofi.

As one of the largest API manufacturers in Europe, our ambition is to be considered an extension of your own internal resources and network. EUROAPI can provide a full CMC service for your drug substance to support your clinical development, up to registration and commercial supply. Your molecule will benefit from a state-of-the-art development and manufacturing network, as well as direct access to powerful technology platforms.

More than 250 scientists support our six commercial facilities, providing 2,000 m³ cGMP for organic synthesis and another 6,000 m³ for microbial fermentation to produce small molecules.

We benefit from excellent regulatory and quality track records with global health agencies to support registration and commercial production.

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Steroids & Hormones

Steroid and hormone production has been a core activity at EUROAPI since the field’s inception nearly a century ago. Today, we produce over 20 APIs with a steroid skeleton through complex chemical routes based on outstanding know-how.

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Opiates & controlled substances

From poppy seed farming to API manufacturing and new controlled substance development, we offer deep synthetic chemistry expertise to respond to technically and financially complex needs, from development right through to commercialization.

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