Alembic Pharma gets USFDA final approval for depression drug, shares up nearly 2%

The company said it has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application (ANDA) for Paroxetine Extended-Release Tablets USP in 25 mg and 37.5 mg strengths.

The approved ANDA makes the tablets equivalent to the reference listed drug product (RLD), Paxil CR Extended-Release Tablets, 25 mg and 37.5 mg, of Apotex Inc.

Paroxetine Extended-Release Tablets are used to treat major depressive disorder, panic disorder, social anxiety disorder, and premenstrual dysphoric disorder. With this, Alembic now has 226 ANDA approvals from USFDA (205 final and 21 tentative).

Shares of Alembic Pharma were trading 0.15% higher at ₹921.6 per equity share at 3:19 PM.

Over the last five trading sessions, Alembic Pharmaceuticals' shares declined 3.76%. The shares further dropped 5.85% over the past month. Similarly, the scrip traded 1.55% lower over the past six months, while it fell 12.22% on a year-to-date basis.

The stock touched its 52-week high of ₹1,303.90 on October 9, 2024 and its 52-week low of ₹725.20 on March 3, 2025. The company’s market capitalisation stands at ₹18,113.29 crore as recorded on September 25.

Alembic Pharmaceuticals Q1 results

In Q1 FY26, Alembic Pharmaceuticals posted a consolidated net profit of ₹154.38 crore, marking a 14.60% YoY rise. This came on consolidated revenue of ₹1,710.72 crore, higher by 9.54% YoY. The growth was driven by robust performance in the US and Rest of World (RoW) generics markets, alongside six ANDA filings and four new product launches in the US during the quarter.

The company’s Profit Before Tax (PBT) stood at ₹190.11 crore, reflecting a 21.07% YoY increase, while EBITDA was reported at ₹288 crore.