Granules receives USFDA nod for Potassium Chloride Extended-Release Tablets USP

Hyderabad: Granules Pharma has received US Food & Drug Administration (USFDA) approval for Potassium Chloride Extended-Release Tablets USP.

It is bioequivalent to the reference listed drug product (RLD), Klor-Con Extended-Release Tablets, 8 mEq (600 mg) and 10 mEq (750 mg), of Upsher-Smith Laboratories, LLC. ( Klor-Con® is a trademark of Upsher-Smith Laboratories, LLC.)

Potassium Chloride ER Tablets are used for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.

The Klor-Con® brand and generic had U.S. sales of approximately $54 million MAT for the most recent twelve months ending in December 2019 according to IQVIA Health.

Granules now have a total of 24 ANDA approvals from US FDA (22 Final approvals and 2 tentative approvals).

Granules India also reported of this event to National Stock Exchange of India Limited, BSE Limited 

Read also: Granules Pharma gets USFDA nod for genetic disorder drug Colchicine

Granules India is an Indian pharmaceutical manufacturing company which was founded in 1984 named as Triton Laboratories located in Hyderabad, India. Granules manufacture varieties of drugs including Paracetamol, Ibuprofen, Metformin and Guaifenesin, on a large scale for customers in the domestic as well as international markets. Granules India Limited entered the CRAMS segment, which focuses on contract research and manufacturing. Granules have seven manufacturing facilities; six are in India while the seventh is through a joint venture with Hubei Bio case in Wuhan, China along with two research centres, at Hyderabad and Pune.

Read also: Granules India gets tentative USFDA nod for generic version of Mucinex ER Tablets