APIs Value Chain

From your project to drug production

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Pierre Fabre value chain for production of your drugs

  • Sourcing of raw materials (Plant cell culture, Botanical Expertise®, Intermediates sourcing )
  • Development (Synthetic route identification, Process and analytical development, Process critical parameters identification, Safety data determination)
  • Industrialization (Process optimization on pre-industrial scale, Pilot and clinical batches production, Process and analytical methods validation)
  • API Production   (Commercial batches production, Quality control and release, Health, Safety and environment)
  • Pharmaceutical formulation (Galenic development, Analytical development, Clinical batches delivery )
  • Production of final dosage form (Aseptic filling of your injectables, Dry & liquid forms, Lozanges ….

Our commitment to Quality, Safety and Environment

As a regular producer of pharmaceutical active ingredients, we operate in full compliance with current Good Manufacturing Practices (GMP, ICHQ7A). We are also regularly inspected by EMA and FDA.

Pierre Fabre regulatory Affairs team prepare, submit and maintain DMFs and cosmetic files for both the Pierre Fabre Group and our partners. We are also deeply involved in REACH regulation and are able to provide useful information to our customers.

We are careful to maximize our production activities whilst at the same time safeguarding human and natural environment. We work continuously to improve our environmental and safety performance and significant investments are made in those areas. Our initiatives led us to be rewarded by the AFAQ ISO 14001, 26000 and OHSAS 18001. 

Waste management is also a key element in our policy.

The Gaillac site was audited by the US health authorities (Food and Drug Administration) in 1993, 1996, 2005, 2008 and  2013.

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