Loures, Portugal, October 29, 2007 - Hovione's Technology Transfer Center (TTC) in New Jersey has just passed successfully a pre-approval inspection by FDA.
The inspection was carried out by Ms. Joy R. Kozlowski-Klena Compliance Officer at the US FDA Center for Drug Evaluation and Research (CDER) and lasted 3 days, starting on October 9th and concluded on the 12th. No form 483 was issued. At the closing meeting, the inspector had several positive comments on our systems and indicated she would be recommending the approval of the site. This inspection covered the TTC's first commercial product - a high potency small molecule API for an injectable formulation. The NDA was filed last May and approval is expected in Q1 2008, with a launch foreseen later that year. Mr. Dave Hoffman, President of the US Operations said “This is an exciting milestone for our New Jersey Technology Transfer Center. This successful FDA compliance inspection gives a green light to an NDA compound - we look forward to further expanding small scale commercial manufacturing opportunities at our NJ site”.
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. In the Establishment Inspection Report issued by Ms. Joy R. Kozlowski-Klena it is 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 TTC site consist of process chemistry R&D labs, cGMP kilo and scale-up labs and a cGMP pilot plant. The TTC is also the home of Hovione’s commercial offices. The TTC offers Hovione´s US based customers’ process development and scale-up services, along with quality control/assurance and regulatory support. The cGMP facility is designed to prepare small quantity NCE’s to support customer's pre-clinical and early-phase clinical development, demonstrating the customer’s processes locally before transferring them to Hovione's full scale manufacturing plants, in Europe and Asia.
Hovione is an international group specializing in the development and compliant production of active pharmaceutical ingredients (APIs), serving exclusively the pharmaceutical industry. With a 48-year track record in process development, quality standard and advanced particle design technologies, Hovione offers APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe, Far East and New Jersey, Hovione is committed to the highest levels of service and quality. Specializing in complex chemistry, Hovione offers services related to the development and manufacture of either a new chemical entity (NCE) for an exclusive contract manufacturing partner or an existing API for an off-patent product.