Jul 17 2010
Apicore LLC announced today that the U.S. Food and Drug Administration (FDA) completed an inspection of its API manufacturing plant in Somerset, New Jersey on July 13, 2010.
“We're pleased with the conclusion of the inspection and look forward to working with our partner to obtain approval to launch the product in the near future.”
The inspection covered plant wide Good Manufacturing Practices (GMP) and was also a Pre-Approval Inspection (PAI) triggered by the review of an Abbreviated New Drug Application (ANDA) that references one of Apicore's Drug Master Files (DMF). At the conclusion of the inspection no form 483 was issued. (Note: Form FDA 483 is used by FDA as a written notice of deviations found during inspections)
The successful conclusion of the inspection is one the final milestones on the path to ANDA approval. It creates an opportunity for Apicore and its partner to enter the market with the first generic version of the brand name drug referenced in the application.
The company, established in 2005, develops and manufacturers APIs at its laboratories and manufacturing plants located in Somerset, NJ, USA and Vadodara, Gujarat, India.
Mr. Ambrose Stafford, Vice President, Apicore LLC said "We're pleased with the conclusion of the inspection and look forward to working with our partner to obtain approval to launch the product in the near future."
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