USFDA APPROVES POTASSIUM CHLORIDE ER CAPSULES FROM GRANULES INDIA

HIGHLIGHTS

  • USFDA has approved potassium chloride ER capsules from Granules India.
  • Potassium Chloride is useful for the treatment of patients suffering from hypokalemia.
  • Potassium Chloride can be helpful in the treatment of in digitalis intoxications.
  • Patients with hypokalemic familial periodic paralysis and metabolic alkalosis can use Potassium Chloride capsules.

United States Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) for Potassium Chloride Extended-Release (ER) Capsules from Granules India. The United States Pharmacopeia (USP) mentioned in the approval letter has been mentioned to be 8 Milliequivalents per litre (mEq) (600 milligram or mg) and 10 mEq (750 mg).

Potassium Chloride ER Capsules from is bioequivalent to the Reference Listed Drug product (RLD), Micro-K ER Capsules, 8 mEq and 10 mEq, of Nesher Pharmaceuticals (USA) LLC. Expected to be launched shortly, the approved product would be manufactured at the Granules India’s Hyderabad facility.

Commenting on the approval, Priyanka Chigurupati, the Executive Director of Granules Pharmaceuticals, said the latest approval was the fourth ANDA approval in the Potassium Chloride product basket offered by Granules India. Chigurupati expressed happiness about USFDA promoting the new ANDA.

Potassium Chloride is useful for the treatment of patients with hypokalemia which can be with or without metabolic alkalosis. Patients with hypokalemic familial periodic paralysis and metabolic alkalosis can use Potassium Chloride capsules. These capsules can also help patients with significant cardiac arrhythmias, states of aldosterone excess with normal renal function, hepatic cirrhosis with ascites, potassium-losing nephropathy, and some of the diarrheal states.

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