Apicore LLC has announced that the FDA completed an inspection of its kilo-scale API manufacturing site in Somerset, New Jersey from December 12, 2008 to December 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. The company, established in 2005, provides process development and manufacturing services according to ICH guidelines related to new chemical entities (NCE) for new drug development clients or existing APIs for off-patent drug products. Specializing in complex chemistry, with a particular expertise in carbohydrate chemistry, Apicore offers a total service package including synthetic route screening, process optimization, scale-up and validation, analytical method development and validation, stability studies and preparation of documentation for submission to regulatory authorities. Mr. Ambrose Stafford, Vice President, Apicore LLC said, “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 United States 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 United States 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 New Jersey and to bringing our multi-ton plant in Vadodara on-line in the near future.”
