Granules India gains after USFDA nod for Potassium Chloride extended-release tablets

Granules India rose 2.37% to Rs 176.8 after the company said it received US drug regulator's approval for Potassium Chloride extended-release tablets.

Granules India in a regulatory filing during market hours today (5 March) announced that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by company's wholly owned foreign subsidiary, for Potassium Chloride extended-release tablets USP, of 600 mg and 750 mg.

The drug is bioequivalent of Klor-Con extended-release tablets of Upsher-Smith Laboratories, LLC. It is 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. According to IQVIA Health, Klor-Con brand and generic had US sales of approximately $54 million MAT for the most recent twelve months ending in December 2019.

 

Granules has a total of 24 ANDA approvals from US FDA (22 Final approvals and 2 tentative approvals).

Granules India is a growing pharmaceutical manufacturing company. The company produces finished dosages (FDs), pharmaceutical formulation intermediates (PFIs) and active pharmaceutical ingredients (APIs).

Powered by Capital Market - Live News