All five Novasep Synthesis sites pass inspections in last three years
Novasep, a French supplier of manufacturing services to the life sciences industries, has this year completed two successful US Food and Drug Administration (FDA) inspections for Novasep Synthesis, its synthetic molecule contract manufacturing division.
All five Novasep Synthesis sites have passed FDA inspections in the last three years, the most recent ones at its Freeport (the Bahamas) facility in March and at its Chasse sur Rhône (Lyon, France) facility in May.
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: US Government Accountability Office).
With 100% of the Novasep production sites inspected successfully during the last three years, the company claims to be in the top tier of CMOs, providing a high degree of quality assurance and security of supply to its customers.
‘Our ability continuously to meet and exceed the FDA 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.
Novasep currently produces around 40 commercial APIs and multiple cGMP intermediates. It also provides purification and synthesis process development and scale-up services for approximately 50 new APIs in development every year, produced in Europe and the Bahamas.