Granules Pharmaceuticals Inc., receives ANDA approval for Prazosin Hydrochloride Capsules

Granules India Limited announced today that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of Granules India Limited, 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 Inc. The product would be available for the US market shortly.

Commenting on the approval Ms. 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 $54 million, according to IQVIA/IMS Health.

Shares of Granules India Limited was last trading in BSE at Rs. 340.15 as compared to the previous close of Rs. 328.25. The total number of shares traded during the day was 95581 in over 2371 trades.

The stock hit an intraday high of Rs. 341.85 and intraday low of 325.70. The net turnover during the day was Rs. 32094825.00.

Source : Equity Bulls

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