Granules India secures USFDA approval for Potassium Chloride Oral Solution
Hyderabad: Granules India Limited announced 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 Oral Solution USP, 20 mEq/15 mL (10%) and 40 mEq/15 mL (20%).
It is bioequivalent to the reference listed drug product (RLD), Potassium Chloride Oral Solution, 20 mEq/15 mL (10%) and 40 mEq/15 mL (20%), of Genus Lifesciences, Inc.
The product would be available in bottle of 473 ml and is expected to be launched shortly.
"We are pleased to announce approval of first oral liquid product from our growing product portfolio in the US market. This is third approval in the Potassium Chloride product basket reiterating our focussed portfolio strategy." said Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals, Inc., commenting on the approval.
Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction are insufficient.
Granules now has a total of 36 ANDA approvals from US FDA (35 Final approvals and 1 tentative approvals).
Potassium Chloride Oral solution products had U.S. sales of approximately $75 million for the most recent twelve months ending in November 2020 according to IQVIA Health.
Granules manufactures varieties of drugs including Paracetamol, Ibuprofen, Metformin, and Guaifenesin, on a large scale for customers in the domestic as well as international markets.