Granules Pharmaceuticals Inc.,Receives ANDA Approval

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

Hyderabad, 28 January 2022: 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.

About Granules India Ltd. (BSE: 532482, NSE: GRANULES)
Granules India Limited, incorporated in 1991 is a vertically integrated fast growing Indian pharmaceutical company headquartered at Hyderabad with best in class facilities and commitment to operational excellence, quality, and customer service. We are among the few pharmaceutical companies in the world to be present in the manufacturing of entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs). Our products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 75+ countries with offices across India, US and UK The Company has 7 manufacturing facilities out of which 6 are located in India and 1 in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.

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