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Granules India gets USFDA nod for its Potassium Chloride ER Capsules USP
February 17, 2021
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Granules India Limited has announced that the US Food & Drug Administration has approved its Abbreviated New Drug Application (ANDA) for Potassium Chloride Extended-Release Capsules USP, 8 mEq (600 mg) and 10 mEq (750 mg).
It is bioequivalent to the reference listed drug product (RLD), Micro-K Extended-Release Capsules, 8 mEq and 10 mEq, of Nesher Pharmaceuticals (USA) LLC. The product would be manufactured at the company’s Hyderabad facility and is expected to be launched shortly.
“We are pleased to announce approval of Potassium Chloride Capsule product within the first review cycle of 10 months from the filing date. This is fourth ANDA approval in our Potassium Chloride product basket,” said Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals, Inc.