Unichem has 20 ANDA approvals from the USFDA.
By Sreekanth A Nair
Pharmaceutical firm Unichem Laboratories has received final Abbreviated New Drug Application (ANDA) approvals from the United States Food and Drug Administration to market alfuzosin hydrochloride extended-release tablets USP.
Alfuzosin hydrochloride extended-release tablets USP 10 mg is therapeutically equivalent to Uroxatral extended-release tablets 10 mg of Concordia Pharmaceuticals Inc.
The medicine is used in the treatment of benign prostatic hyperplasia in adults.
Alfuzosin hydrochloride extended-release tablets USP is the company’s first PARA IV ANDA approval from the USFDA.
“The product will be commercialized from Unichem’s Goa plant. The active pharmaceutical ingredients (API) for the product would also be made in-house at Pithampur plant,” the company said, in a statement.
Unichem Laboratories now has a total of 20 ANDA approvals from the USFDA.