USFDA completes inspection at Alembic Pharmaceuticals’ Panelav units

30 Jun 2016 Evaluate

Alembic Pharmaceuticals' API Facilities i.e. API I and API II both located at Panelav have been successfully inspected by the USFDA between June 20, 2016 and June 29, 2016. The company did not receive any Form 483 observations.

Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification. The launch of this product will be based on the outcome of the ongoing litigation in the United States District Court for the District of Delaware with UCB. Alembic now has a total of 47 ANDA approvals (43 Final approvals and 4 tentative approvals) from USFDA.

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