The US drug regulator has approved the drug maker's abbreviated new drug application (ANDA) for potassium chloride extended-release capsules USP, 8 mEq (600 mg) and 10 mEq (750 mg).
The product is a bioequivalent to the reference listed drug product (RLD), Micro-K extended-release capsules, 8 mEq and 10 mEq, of Nesher Pharmaceuticals (USA) LLC. The product would be manufactured at the company's Hyderabad facility and it is expected to be launched shortly.
Commenting on the approval, Priyanka Chigurupati, executive director, Granules Pharmaceuticals, Inc., said: We are pleased to announce approval of Potassium Chloride Capsule product within first review cycle of 10 months from filing date. This is fourth ANDA approval in our Potassium Chloride product basket.
Potassium chloride is indicated for the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxications, and in patients with hypokalemic familial periodic paralysis. It is also indicated for the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop e.g., digitalized patients or patients with significant cardiac arrhythmias, hepatic cirrhosis with ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, and certain diarrheal states.
Potassium chloride ER capsule products had U.S. sales of approximately $43 million for the most recent twelve months ending in December 2020 according to IQVIA Health.
Granules now has a total of 37 ANDA approvals from US FDA (36 final approvals and 1 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). The company's global presence extends to over 250 customers in 60 countries through offices in India, US, and UK.
On a consolidated basis, the drug maker 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.
The scrip fell 2.59% to Rs 342 on the BSE. In the past three months, the stock has declined by 11.23% while the benchmark Sensex has added 17.71% during the same period.
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