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Third Isochem site receives FDA audit
Vert-Le-Petit, France: – inspector representing the U.S. Food and Drug Administration has audited the Isochem S.A.S. specialist phosgene chemistry site for the first time and awarded it a 100% seal of approval with no issues recorded on Form 483 for attention or correction.
The addition of the Vert-Le-Petit production site to the FDA audited list means that three of Isochem’s six production sites are now compliant with US Good Manufacturing Practice (cGMP).
The latest inspection came weeks after an FDA audit of Isochem’s Pithiviers site at the end of May. For the third time on succession, the inspectors did not log any Form 483 issues. The FDA has also approved Gennevilliers site for manufacture of active pharmaceutical ingredients (APIs) for U.S. markets with just two minor Form 483 issues in March 2014.
“These highly successful inspections are very good news for Isochem,” commented Xavier Jeanjean, Isochem’s Vice-President for Sales and Commercial Development.
“These are the reward for all the hard work and attention we have put into reviewing standards and processes at our plants to bring them up to full cGMP standard,” said Mr. Jeanjean.
Long term strategy
Submission of plants to full FDA audit is part of the French-based contract manufacturer’s current strategy of pursuing cGMP processes and up scaling its specialist production facilities to support its core business models, principally exclusive industrial custom synthesis and supply of APIs, excipients, regulated and non regulated intermediates.
Meeting cGMP standards is also vital in being able to deliver route selection, process and analytical development and process optimization from laboratory scale to full production, as well as delivery of safe implementation of hazardous reactions and versatile chemistry and state-of-the –art experience in phosgene chemistry, which require highly developed capabilities in multi-step chemical synthesis and very strong expertise in hazardous chemistry.
“Isochem is committed to produce ingredients, implementing complex reactions and technologies, in full compliance with EHS and international quality standards. Increasingly, our clients in the pharmaceutical, foods and agrochemicals industries demand ultimate standards of quality and traceability and recognise the true value of the facilities and expertise we offer,” said Mr. Jeanjean.
Through its UK subsidiary, Wychem, Isochem also recently became a member of Britest (Best Route Innovative Technology Evaluation and Selection Techniques), the not for profit network of leading global businesses and academic institutions committed to share knowledge and risk in defining innovative solutions for key manufacturing challenges to create new value for the chemical processing sector.
Isochem S.A.S. is a contract manufacturer with a century-old heritage in fine chemistry and a 40-year track record in providing high quality fine chemicals, APIs and substances and mastering complex processes. The company can manufacture products and provide services to the most recent and stringent pharmaceutical regulatory standards.
Isochem serves a broad range of customers in many application fields, from leading global companies to virtual and emerging organizations, offering services in three pharma-related fields: custom synthesis, high technology manufacturing in multi-step chemical synthesis including the safe implementation of hazardous reactions, and direct supply of more than 2,300 specific compounds and products, including phosgene derivatives, regulated and non-regulated intermediates and active ingredients.
Isochem can also provide attractive synthetic tools such as activated aminoacids building blocks (N-CarboxyAnhydride) used in peptide chemistry. It is also expert in process optimization from pre-clinical development to full-scale production.
Isochem is now an international company with some 500 employees worldwide. The Head office is located near Paris, in Vert-Le-Petit, France, on one of Isochem’s six manufacturing sites. The company is a wholly owned subsidiary of Munich-based Aurelius AG.
Xavier Jeanjean, Vice President Sales and Commercial Development, Isochem S.A.S.
Tel: +33 (0) 1 64 99 05 50