Comments
The US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc (GPI)., a wholly-owned foreign subsidiary of Granules India Ltd, for potassium chloride for oral solution USP, 20 mEq.
Potassium chloride is used to prevent or to treat low blood levels of potassium (hypokalemia). It is bioequivalent to the reference listed drug product, Potassium Chloride for Oral Solution, 20 mEq, of Pharma Research Software Solution, LLC. The product would be available for the US market shortly.
Related Stories
NeoCov coronavirus found in bats may pose threat to humans in future, scientists caution
The yet-to-be peer-reviewed study by the Chinese Academy of Sciences and Wuhan University shows close relation between NeoCov and MERS“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,” Priyanka Chigurupati, Executive Director, GPI, said in a press statement.
Granules now has a total of 49 ANDA approvals from the USFDA (47 final approvals and two tentative approvals).
The current annual US market for Potassium Chloride for Oral Solution USP, 20 mEq is approximately $44 million, according to MAT Nov 2021, IQVIA/IMS Health.
Comments
COMMENT NOW
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.