The company now have a total of 24 ANDA approvals from US FDA (22 Final approvals and 2 tentative approvals).
Granules India share price gained 4 percent intraday on March 5 after the company received USFDA nod for Potassium Chloride Extended-release tablets.
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 company 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.
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.
The company now have a total of 24 ANDA approvals from US FDA (22 Final approvals and 2 tentative approvals).
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