Granules receives nod for potassium chloride for oral solution

Hyderabad: Granules India said on Friday that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly owned foreign subsidiary of Granules India, for Potassium Chloride for Oral Solution USP, 20 mEq. Potassium chloride is used to prevent or to treat low […]

Hyderabad: Granules India said on Friday that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly owned foreign subsidiary of Granules India, for Potassium Chloride for Oral Solution USP, 20 mEq.

Potassium chloride is used to prevent or to treat low levels of potassium in blood (hypokalemia). It is bioequivalent to the reference listed drug product, Potassium Chloride for Oral Solution, 20 mEq, of Pharma Research Software Solution. The product would be available for the US market shortly.

Granules now have a total of 49 ANDA approvals from US FDA (47 Final approvals and 2 tentative approvals).

The current annual US market for Potassium Chloride for Oral Solution USP, 20 mEq is approximately $44 million (over Rs 330 crore), according to MAT Nov 2021, IQVIA/IMS Health.

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