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Novasep Passes FDA Inspections

Synthesis sites in France, Bahamas pass muster

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Novasep Synthesis has completed two successful FDA inspections in 2011. The inspections covered its sites in Freeport (Bahamas) in March 2011 and Chasse sur Rhône (Lyon, France) in May 2011. All five Novasep Synthesis sites passed FDA inspections in the last three years.

“Our ability to continuously meet and exceed FDA and EMA requirements is as important as our technology leadership in purification and synthesis. We will maintain our production track record and our continued commitment to quality,” said Patrick Glaser, president of Novasep Synthesis, the synthetic molecule contract manufacturing division of Novasep.

A company statement contrasted its 100% inspection coverage with the fact that, between 2007 and 2009, an average of only 11% of API producers – 107 out of 920 FDA registered products – were inspected in China, and approximately 33% in other regions, including India and Europe (source: U.S. Government Accountability Office).

The company currently produces approximately 40 commercial APIs and multiple cGMP intermediates, and also provides purification and synthesis process development and scale-up services.

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