US FDA Approves Granules’ Blood Pressure Tablets


Granules India announced that its Abbreviated New Drug Application (ANDA) for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg, received approval from the US Food and Drug Administration (FDA). Losartan Potassium is a bioequivalent to the reference recorded drug item (RLD), Cozaar Tablets of Organon LLC.

The US Food and Drug Administration (FDA) has granted Granules 54 ANDA approvals, including 52 final approvals and 2 tentative approvals. To lower blood pressure, losartan potassium tablets are indicated for the treatment of hypertension in adults and children aged 6 and older.

According to Medication-assisted Treatment (MAT) December 2022, IQVIA/IMS Health, the current annual US market for Losartan potassium tablets is approximately $336 million.

Granules India began as Triton Laboratories in 1984. In its Bonthapally factory on the outskirts of Hyderabad, Triton produced Paracetamol API. The Paracetamol API was produced in a more effective manner by Triton scientists, resulting in lower capital and raw material requirements. Except for Dr. Reddy’s Laboratories, Triton was the only Indian company to export pharmaceutical products to the United States in 1987.

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