Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated September 25, 2025, titled "Alembic Pharmaceuticals Limited receives USFDA Final Approval for Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg".
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Alembic Pharmaceuticals has received final approval from the USFDA for its generic version of Paroxetine Extended-Release Tablets in 25 mg and 37.5 mg strengths. This is therapeutically equivalent to Apotex's Paxil CR, used for treating depression, panic disorder, social anxiety disorder, and PMDD. With this approval, the company's cumulative ANDA tally from USFDA rises to 226 (205 final approvals and 21 tentative approvals). The approval allows Alembic to manufacture and market this generic drug in the US market, strengthening its US generics portfolio.
Positive for shareholders — adds another product to Alembic's US generics pipeline and reinforces its track record of USFDA approvals, which supports future export revenue from the US market.