Unichem Lab receives final ANDA approval for Alfuzosin Hydrochloride Tablets

29 Jan 2016 Evaluate

Unichem Laboratories has received Final ANDA approval (Tentative Approval was received earlier) from the United States Food and Drug Administration (USFDA) for Alfuzosin Hydrochloride Extended-Release Tablets USP. Alfuzosin Hydrochloride Extended-Release Tablets USP 10mg is therapeutically equivalent to Uroxatral Extended-release Tablets, 10 mg, of Concordia Pharmaceuticals, Inc. (Concordia).

Alfuzosin Hydrochloride Extended-Release Tablets USP is the company's first PARA IV ANDA approval from the USFDA. Alfuzosin MCI is an alpha adrenergic antagonist, indicated for the treatment of signs and symptoms of benign prostatic hyperplasia in adults. The product will be commercialized from the company’s Goa plant. Active Pharmaceutical Ingredient will also be made in house at Pithampur API Plant.  The company now has total of 20 ANDA approvals from USFDA. 

Unichem Laboratories is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world.

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