Alembic Pharma Gets USFDA Nod for Paroxetine ER

Vadodara, September 25, 2025: Alembic Pharmaceuticals Ltd (NSE: APLLTD, BSE: 533573) has received final USFDA approval of its ANDA filing of Paroxetine Extended-Release Tablets 25 mg and 37.5 mg, the therapeutic equivalents of Apotex’s Paxil CR. With the approval, Alembic’s ANDA portfolio stands at 226 — 205 final and 21 tentative.

Stock Market Reaction

Following the announcement, Alembic’s stock saw modest movement. It closed at ₹915.00, down approximately 0.57% from the previous session. The performance suggests that while the USFDA approval was viewed positively, the market had largely priced in the news, given Alembic’s strong track record of securing regulatory approvals.

Recent Regulatory Momentum

This clearance follows a series of regulatory successes for Alembic. In the first week of September, the company received USFDA approval for its Phytonadione injectable emulsion ANDA, a niche product with an estimated US addressable market of around USD 44 million. Beyond generics, Alembic has also expanded into specialty and neurology segments, reflecting a strategic focus on high-growth areas.

The Paroxetine nod solidifies Alembic’s position in central nervous system (CNS) therapies in the U.S. marketplace. It also increases faith in the company’s regulatory competence and executional discipline. Yet, with high competition in U.S. generics, ensuring manufacturing compliance, cost leadership, and timely launches will be essential to convert approvals into significant revenue.

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