
USFDA nod for Granules Potassium Chloride ER Capsules
The Hindu
The US Food and Drug Administration (USFDA) has approved drugmaker Granules India’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 bioequivalent to the reference listed drug Micro-K Extended-Release Capsules, 8 mEq and 10 mEq, of Nesher Pharmaceuticals (USA). A release from Granules said the product will be manufactured at the company’s Hyderabad facility and expected to be launched shortly.
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