Alembic Pharmaceuticals Limited announced today that it has received final approval from the US Food and Drug Administration (FDA) for its Paliperidone Extended-Release Tablets. The approval covers tablets in 1.5mg, 3mg, 6mg, and 9mg strengths, which are therapeutically equivalent to Janssen Pharmaceuticals’ Invega Extended-Release Tablets.
The shares of Alembic Pharmaceuticals Limited were trading at ₹1,179.95 down by ₹15.80 or 1.32 per cent on the NSE today at 3.15 pm.
The approved drug is an atypical antipsychotic used for treating schizophrenia and schizoaffective disorder. According to IQVIA data, the estimated market size for these tablets is $48 million for the twelve months ending June 2024.
This approval brings Alembic’s total FDA approvals to 215, including 187 final approvals and 28 tentative approvals. The company, founded in 1907, is a vertically integrated pharmaceutical firm headquartered in India. Alembic manufactures and markets generic pharmaceutical products globally, with “state-of-the-art” research and manufacturing facilities approved by regulatory authorities in many developed countries.