With a long tradition manufacturing active pharmaceutical ingredients, ISOCHEM established very early a common Quality Assurance System to all its R&D and manufacturing sites. All sites are now certified Iso 9001:2000.

ISOCHEM's productions are performed in accordance with customer's requirements in terms of Quality, the most stringent being the Pharmaceutical Industry's criteria. Active Pharmaceutical Ingredients and registered intermediates are produced according to the current Good Manufacturing Practices (cGMP) in facilities regularly audited by our customers and inspected by Authorities such as the US Food and Drugs administration (FDA) and the French Agency AFSSAPS.

ISOCHEM presently operates 3 of its manufacturing plants according to cGMP (as defined in ICH-Q7) and 2 of them are regularly inspected by the FDA.

Total: 14 FDA audits
The latest FDA audit of ISOCHEM was completely successful (No 483 form), proving the maturity and efficiency of our quality management system.

NEWS "French agency AFSSAPS currently audits ISOCHEM: API portfolio. AFSSAPS has delivered a cGMP certificate to 21 products (API and excipients)".

In parallel, ISOCHEM brings all the necessary regulatory support such as registration of new sustances or DMF filing. More than 35 DMF groups were filed by ISOCHEM.