Granules India gets USFDA nod for generic potassium chloride oral solution

The US drug regulator has approved the ANDA filed by Granules Pharmaceuticals, Inc, a wholly owned foreign arm of Granules India, for potassium chloride oral solution USP, 20 mEq/15 mL (10%) and 40 mEq/15 mL (20%).

The product is bio-equivalent 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 reduction are insufficient. Granules now has a total of 36 ANDA approvals from USFDA (35 final approvals and 1 tentative approvals).

According to IQVIA Health, potassium chloride oral solution products had U.S. sales of approximately $75 million for the most recent twelve months ending in November 2020. The announcement was made during trading hours today, 1 February 2021.

On a consolidated basis, Granules India reported 129.30% jump in net profit to Rs 146.81 crore on a 20% rise in net sales to Rs 844.51 crore in Q3 FY21 over Q3 FY20.

Shares of Granules India fell 2.82% to Rs 327.65. Granules India is a pharmaceutical manufacturing company. The company produces Finished Dosages (FDs), Pharmaceutical Formulation Intermediates (PFIs) and Active Pharmaceutical Ingredients (APIs) which gives the customers flexibility and choice. Granules has a total of 36 ANDA approvals from US FDA (35 final approvals and 1 tentative approvals).

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