Hovione’s Technology Transfer Center (TTC) in New Jersey has passed successfully a pre-approval inspection by FDA. The three-day inspection was carried out by Ms. Joy R. Kozlowski-Klena, a compliance officer at FDA’s Center for Drug Evaluation and Research (CDER). No form 483 was issued.

This inspection covered the center’s first commercial product, a high potency small molecule API for an injectable formulation. The NDA was filed in May and approval is expected in Q1 2008, with a launch foreseen later in the year.

Hovione plants have been object of 15 FDA inspections. This inspection is the first at the New Jersey since it started to operate as an R&D facility in September 2002. Ms. Kozlowski-Klena’s Establishment Inspection Report stated, “This inspection covered the NDA under evaluation, as well as limited GMP coverage of systems in place at this time, including Quality, Laboratory, Production, Facilities and Equipment. The inspection did not reveal any significant deficiencies.”

The site serves as Hovione’s U.S. Operations HQ, and consist of process chemistry R&D labs, cGMP kilo and scale-up labs and a cGMP pilot plant, as well as Hovione’s commercial offices. The cGMP facility is designed to prepare small-quantity NCEs to support preclinical and early-phase clinical development, demonstrating processes locally before transferring them to Hovione’s full-scale manufacturing plants, in Europe and Asia.