HQ Team
February 27, 2023: Granules India announced the US Food & Drug Administration (US FDA) had approved an Abbreviated New Drug Application (ANDA) for losartan potassium tablets to treat high blood pressure.
It is bioequivalent to the reference listed drug product (RLD), Cozaar tablets of Organon LLC. Granules now have 54 ANDA approvals from US FDA — 52 final approvals and two tentative approvals.
Losartan potassium tablets are used for treating hypertension in adults and pediatric patients six years of age and older to lower blood pressure.
The current annual US market for losartan potassium tablets is approximately $336 million, according to IQVIA-IMS Health.
An Abbreviated New Drug Application is an application for a US generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product.
Granules India is a pharmaceutical manufacturing company based in Hyderabad, India. Granules manufacture several off-patent drugs, including paracetamol, ibuprofen, metformin and guaifenesin, for customers in the regulated and rest of the world markets.
