Granules India announced today that the US Food & Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of Granules India for prazosin hydrochloride capsules, USP 1mg, 2mg & 5mg. It is bioequivalent to the reference listed drug product (RLD), Mini plus capsules 1Mg, 2Mg & 5 Mg of Pfizer. The product would be available for the US market shortly.

Commenting on the approval Priyanka Chigurupati, Executive Director, GPI, said "We are pleased to receive the approval of the product and will surely be a valuable addition to our growing product portfolio in the US market."

Granules now has a total of 46 ANDA approvals from US FDA (44 final approvals and 2 tentative approvals).

The current annual U.S. market for prazosin hydrochloride 1mg, 2mg, 5mg strengths is approximately US $ 54 million, according to IQVIA/IMS Health.