Granules surge post USFDA nod for Potassium Chloride tablets

US Food & Drug Administration (USFDA) has approved Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI), a wholly-owned foreign subsidiary of Granules India Limited for Potassium Chloride Extended-Release Tablets USP, 8 mEq (600 mg) and 10 mEq (750 mg).

It is bioequivalent to the Reference Listed Drug product (RLD), Klor-Con Extended- Release Tablets, 8 mEq (600 mg) and 10 mEq (750 mg) of Upsher-Smith Laboratories, LLC. (Klor-Con is a trademark of Upsher-Smith Laboratories, LLC). As per IQVIA Health data, for the recent twelve-month ending December 2019, Klor-Con brand and generic had US sales of approximately $54 million MAT. 

Potassium Chloride ER Tablets are used 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 is insufficient.

Hypokalemia is when blood’s potassium levels are too low. Potassium is an important electrolyte for nerve and muscle cell functioning, especially for muscle cells in the heart. The kidney controls the body’s potassium levels, allowing for excess potassium to leave the body through urine or sweat.

Granules now have a total of 24 ANDA approvals from USFDA (22 final approvals and two tentative approvals).

On Thursday, the stock of Granules India surged 4.1 per cent making intra-day high of Rs 179.80 from its previous close of Rs 172.70 on BSE.