The FDA completed an inspection of Apicore LLC‘s kilo-scale API manufacturing site in Somerset, NJ. The inspection took place December 12-15, 2008, according to Compliance Program 7356.002F, “Drug Manufacturing Inspections for Bulk Pharmaceutical Chemicals.” This was the second successful inspection of the site since 2006.

Apicore provides process development and manufacturing services according to ICH guidelines for new chemical entities (NCE) and existing APIs for off-patent drug products.

Ambrose Stafford, Apicore’s vice president, remarked, “We’re very proud that after just four years in operation our team has demonstrated a culture of GMP compliance and technical excellence. Our track record gives our clients confidence. Our facility in the U.S. enables us to cooperate efficiently with our clients’ teams to achieve our common objectives of on-time supply of clinical trial materials and prompt approval of our client’s drug product filings. The multi-ton facility that we’re constructing in Vadodara, India creates a low-cost base for manufacturing larger volumes than can be produced at our New Jersey site. Managing the total operation from the U.S. enables us to provide the combination of excellent service and low costs that our customers demand. We look forward to further expanding small-scale API manufacturing in NJ and to bringing our multi-ton plant in Vadodara on-line in the near future.”