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Granules India gets USFDA nod for generic product

The US Food & Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) for Potassium Chloride for Oral Solution filed by Granules Pharmaceuticals Inc (GPI), a wholly-owned foreign subsidiary of the company.

January 28, 2022 / 03:44 PM IST
 
 
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Drug firm Granules India on Friday said it has received approval from the US health regulator to market Potassium Chloride, which is used to treat low blood levels.

The US Food & Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) for Potassium Chloride for Oral Solution filed by Granules Pharmaceuticals Inc (GPI), a wholly-owned foreign subsidiary of the company.

Potassium Chloride is used to prevent or to treat low blood potassium levels (hypokalemia).

The product would be available for the US market shortly, Granules India said in a statement.

"We are pleased to receive the approval of the product and will surely be a valuable addition to our growing product portfolio in the US market,” GPI Executive Director Priyanka Chigurupati noted.

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Granules stated that it now has a total of 49 ANDA approvals from the USFDA.

According to MAT Nov 2021, IQVIA/IMS Health data, the current annual US market for Potassium Chloride for Oral Solution is around USD 44 million.



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PTI
first published: Jan 28, 2022 03:44 pm
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