Novasep, a leading supplier of manufacturing solutions to the life sciences industries, announces today that it has completed two successful US Food and Drug Administration (FDA) inspections for Novasep Synthesis in 2011. All five Novasep Synthesis sites passed FDA inspections in the last three years, the most recent ones at its Freeport (the Bahamas) facility in March 2011 and at its Chasse sur Rhône (Lyon, France) facility in May 2011 prompting no remarks.
Between 2007 and 2009 an average of only 11 percent of API producers – 107 out of 920 FDA registered products – were inspected in China, and approximately 33 percent in other regions, including India and Europe (source US Government Accountability Office). In contrast, with 100 per cent of the Novasep production sites inspected successfully in the last three years, Novasep resides in the top tier of CMOs, providing a high degree of quality assurance and security of supply to its customers.
“Our ability to continuously meet and exceed the FDA (and the EMA, its European equivalent) 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. “Our unique scope of synthesis and purification technologies and know-how enables us to efficiently produce the increasingly complex molecules of today and tomorrow at the highest level of purity, and Novasep is the only company that combines this expertise with such an excellent quality and regulatory track record.”
Novasep currently produces approximately 40 commercial APIs and multiple cGMP intermediates. Also, it provides purification and synthesis process development and scale-up services for approx 50 new APIs in development every year, produced in Europe and the Bahamas with the highest level of efficiency and compliance.
Novasep develops, markets and operates innovative technologies providing life science industries with safe and cost-effective production of active molecules. The global manufacturing solutions offered by Novasep include process development services; purification equipment and systems; contract manufacturing services; and complex active molecules. The applications of Novasep’s offering cover the pharmaceutical, biopharmaceutical, food, functional ingredients and bio-industries markets. http://www.novasep.com