Unichem Laboratories has received ANDA tentative approval from the United States Food and Drugs Administration (USFDA) for Irbesartan. Final approval will be received after the patent expires on Dec 7, 2015.
Irbesartan Tablets 75mg, 150mg and 300mg are therapeutically equivalent to Avapro Tablets 75mg, 150mg and 300mg from Sanofi Aventis US, LLC. Irbesartan is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.
The product will be commercialized (after the final approval) from Unichem's Ghaziabad plant, Active pharmaceutical ingredient i.e., Irbesartan used for this ANDA is also made in house at Pithampur plant. The current market size is $450 million.
Unichem Laboratories, incorporated in 1962, is engaged in manufacturing formulations, pharmaceuticals and active pharmaceutical ingredients (APIs). The company was promoted by the late Amrut Mody, a pioneer in the Indian pharmaceuticals business.
