Granules India 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, 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.
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