Granules Pharmaceuticals, Inc. Receives ANDA Approval for Potassium Chloride for Oral Solution USP, 20 mEq

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 Potassium Chloride for Oral Solution USP, 20 mEq. Potassium chloride is used to prevent or to treat low blood levels of potassium (hypokalemia). It is bioequivalent to the reference listed drug product, Potassium Chloride for Oral Solution, 20 mEq, of Pharma Research Software Solution, LLC. 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 have a total of 49 ANDA approvals from US FDA (47 Final approvals and 2 tentative approvals).

The current annual U.S. market for Potassium Chloride for Oral Solution USP, 20 mEq is approximately $44 million, according to MAT Nov 2021, IQVIA/IMS Health.

Shares of Granules India Limited was last trading in BSE at Rs. 300.50 as compared to the previous close of Rs. 294.10. The total number of shares traded during the day was 110379 in over 3894 trades.

The stock hit an intraday high of Rs. 307.90 and intraday low of 294.00. The net turnover during the day was Rs. 33397164.00.

Source : Equity Bulls

Keywords

GranulesIndia INE101D01020 PotassiumChlroideOralSolution USFDA ANDAApproval