Granules rises after USFDA approval for generic drug

Granules India rose 1% to Rs 389.35 after the company received US drug regulator's approval for generic potassium chloride tablets for the treatment of Hypokalemia.

Granules India announced that it has received marketing approval from the US Food and Drug Administration (USFDA) for potassium chloride extended release tablets USP, 10 mEq (750 mg) and 20 mEq (1500 mg) for the treatment of patients with hypokalemia. Granules' tablet product is bioequivalent to the reference listed drug (RLD), K-Dur.

According to IQVIA Health, potassium chloride extended release tablets USP, 10 mEq & 20 mEq had US generic sales of approximately $204 million for the most recent twelve months ending in August 2020.

The drug will be manufactured at the Granules manufacturing facility in Gagillapur, Hyderabad. Granules now have a total of 34 ANDA approvals from the US FDA (32 Final approvals and 2 tentative approvals).

Priyanka Chigurupati, executive director of Granules Pharma said, "This approval from Granules India, received within 10 months of filing reiterates our strength in the development of complex generics. The approval of potassium chloride extended release tablets USP, 10 mEq & 20 mEq, a complex MUPS (multi-unit pellet system)based formulation, equivalent to generic K-Dur, and Klor Con M, is a good addition to our portfolio. We will be launching this product from our Gagillapur site in Hyderabad, India."

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.

The pharma company reported 70.8% jump in consolidated net profit to Rs 164 crore on a 22.7% rise in income from operations to Rs 858 crore in Q2 FY21 over Q2 FY20.

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