India Pharma Outlook Team | Monday, 30 March 2026
Alembic Pharmaceuticals Limited has secured USFDA approval for Paroxetine Extended-Release Tablets USP 12.5 mg, marking another step forward in its growing U.S. generics portfolio.
The approval comes from the US Food and Drug Administration for the company’s supplemental Abbreviated New Drug Application (sANDA).
The newly approved drug is therapeutically equivalent to Paxil CR Tablets (12.5 mg), a reference listed drug marketed by Apotex Inc. Paroxetine Extended-Release Tablets are widely prescribed for treating major depressive disorder (MDD), panic disorder (PD), social anxiety disorder (SAD), and premenstrual dysphoric disorder (PMDD). This USFDA approval for Paroxetine Extended-Release Tablets strengthens the company’s position in the regulated U.S. market.
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With this latest nod, Alembic Pharmaceuticals Limited now holds a total of 235 ANDA approvals from the USFDA, including 216 final approvals and 19 tentative ones. The milestone highlights its steady progress in expanding its generics pipeline and regulatory footprint.
Alembic Pharmaceuticals, a research-driven and vertically integrated pharma company, has over a century-long legacy. Headquartered in India, it manufactures and markets a broad range of generic medicines globally. Its facilities meet strict regulatory standards and are approved by top global authorities, including the USFDA.
The company also maintains a strong presence in India’s branded generics market, backed by a field force of more than 5,500 professionals. It continues to invest in complex generics and specialty segments while expanding its product pipeline.
This approval underlines Alembic’s focus on delivering high-quality, affordable medicines and reinforcing its global pharmaceutical footprint.
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