Alembic Pharmaceuticals Limited has informed the Exchange regarding a press release dated March 27, 2026, titled "Alembic Pharmaceuticals Limited receives USFDA Final Approval for Paroxetine Extended-Release Tablets USP, 12.5 mg.".
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Alembic Pharmaceuticals has received final approval from the USFDA for its supplemental Abbreviated New Drug Application (sANDA) for Paroxetine Extended-Release Tablets USP, 12.5 mg. The product is therapeutically equivalent to Apotex's Paxil CR Tablets and is indicated for treating major depressive disorder, panic disorder, social anxiety disorder, and premenstrual dysphoric disorder. This approval adds to Alembic's cumulative tally of 235 ANDA approvals from the USFDA, comprising 216 final and 19 tentative approvals. The company did not disclose expected revenue from this specific product.
Marginally positive for shareholders — strengthens Alembic's US generics portfolio and adds another revenue stream in the US market, though Paroxetine ER is not a high-value launch and the financial impact is likely modest. Overall, it reflects the company's steady ANDA approval pipeline.