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The Quality department of PHARMASYNTHESE guarantees quality, traceability, compliance and continuous improvement of operations and performance.

PHARMASYNTHESE is ISO 9001 certified since 1998.

In February 2017, PHARMASYNTHESE was granted the renewal of its GMP certificate by the French Health agency ANSM. The certificate covers APIs manufactured at Saint Pierre les Elbeuf facility.



PHARMASYNTHESE was granted several CEPs by the European Health Agency for its active ingredients:


Products Type Date
AMOROLFINE HYDROCHLORIDE CEP R1-CEP 2016-312-Rev 00 15/02/2018
DIBUCAINE HCL CEP R1-CEP 2007-117-Rev 00 20/02/2019
FENTICONAZOLE NITRATE CEP R0-CEP 2015-157-Rev 02 01/06/2017
SERTACONAZOLE NITRATE CEP R0-CEP 2015-066-Rev 01 06/07/2017


4 APIs are registered into the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and obtained Drug Master File to address Japanese pharmaceutical market.

Audits are conducted on a monthly basis by worldwide pharmaceutical companies.

INABATA France implemented the Good Distribution Practices (GDP) for the distribution of Active Pharmaceutic Ingredients.

We are supplying Pharmaceutical and Cosmetic ingredients in Europe, Japan and the rest of the world.

Every year, an important part of the profits is reinvested into various areas of our production site to upgrade the facility in terms of GMP, EHS and productivity.

Quality control laboratory

The laboratory covers a total surface of 160 m2.

Air and access are controlled.

Employees must use an airlocked dressing room as well as a pass-through window for the transmission of samples and documents.


 The laboratory is fully equipped with:

  • 5 HPLC chains
  • 4 GC chains including 2 head space chromatographs
  • 1 IR spectrophotometer
  • 1 UV spectrophotometer
  • 1 polarimeter
  • 1 refractometer
  • 1 DSC (Differential Scanning Calorimetry) instrument

Only a few analyses are subcontracted through a partnership with an academic laboratory: microbiology, particle size assay and NMR/X-Rays.