FDA Approves Two Novasep API Facilities In France
By Cyndi Root
Novasep, a contract development and manufacturing organization (CDMO), announced in a press release that the Food and Drug Administration (FDA) has approved two of its active pharmaceutical ingredient (API) facilities in France. The pre-approval inspections in Chasse-sur-Rhone and Pompey, France allow the company to produce new molecular entities (NMEs) for the U.S. market. The recent approvals follow successful inspections in 2013 at Novasep plants in Le Mans, Mourenx, and Leverkusen. Jean Claude Romain, VP of Quality at Novasep, said, “Our teams at Novasep invest in and conduct continuous upgrades to ensure that ever stricter regulatory standards meet the highest level of compliance at all Novasep plants.”
FDA Site Approvals
The FDA approved the Chasse-sur-Rhone and Pompey sites in June 2014. The facilities are equipped for kinase inhibitor synthesizing and purifying. At Chasse-sur-Rhone, the company synthesizes the active pharmaceutical ingredient (API) and late-stage intermediates. At Pompey, Novasep finishes the last purification step. The facilities are both managed according to Good Manufacturing Practices (GMP).
About Novasep
Novasep is a French company, founded in 1996. It offers development services, contract manufacturing services, and production of synthetic molecules and biomolecules. It has three business units — Synthesis BU, Biopharma BU, and Industrial Biotech BU. The company has facilities in Europe, Asia, and North America, including Massachusetts, Pennsylvania, and the Bahamas. Asian facilities include China, Japan, and India.
In June, Novasep announced that its Asian subsidiary obtained a contract with Tay Ninh Chemical Industry (Tanichem) worth EUR 7.5 million. Novasep will erect the plant, procure process equipment, and provide engineering and field services for a sorbitol plant in Vietnam. Sorbitol is a stabilizer used in drugs and other products.
Novasep also announced recently that it will be expanding its highly potent active pharmaceutical ingredients (HPAPI) plant in Le Mans in order to produce antibody drug conjugates (ADCs).