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Alembic Pharmaceuticals gets USFDA approval for its NDA - Desvenlafaxine Base ER Tablets

05 Mar 2013 Evaluate

Alembic Pharmaceuticals has received approval from the USFDA for its NDA, Desvenlafaxine Base Extended Release (ER) Tablets, a bioequivalent version of innovator drug, Pristiq by Pfizer. The company is the sponsor and manufacturer of the NDA. Desvenlafaxine Base Extended Release Tables is Alembic's first 505 (b) (2) filing.

Further, the company has entered into an out-licensing arrangement with Ranbaxy Pharmaceuticals Inc (Ranbaxy), a wholly owned subsidiary of Ranbaxy Laboratories for exclusively marketing the product in the United States of America. The product will be available in 50 mg and 100 mg dosage strengths. The parties will launch the product immediately.

Desvenlafaxine Base Extended Release Tablets is a prescription medicine that is indicated for the treatment of major depressive disorder. The current market size for Pristiq is approximately $ 538 million, based on industry sales data.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907. The company manufactures and markets generic pharmaceuticals products all over the world.

Alembic Pharma Share Price

763.55 4.55 (0.60%)
21-Apr-2026 16:59 View Price Chart
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