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news.FDA has completed inspection in Apicore's API manufacturing plant in Somerset, New Jersey. 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).
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According to Apicore, the inspection was concluded successfully and it acts as a final milestone on the path to ANDA approval.
Apicore said that following this milestone, Apicore and its partner can now enter the market with the first generic version of the brand name drug referenced in the application.
Ambrose Stafford, vice president of Apicore, 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.”
The US-based Apicore develops and manufacturers APIs at its laboratories and manufacturing plants located in Somerset, NJ, USA and Vadodara, Gujarat, India.