Granules India gets USFDA nod for hypertension generic drug
Granules India on September 30 announced that it received a nod from the United States Food and Drug Administration (USFDA) for its new drug that is a generic equivalent of a listed drug used in the treatment of hypertension. The American medicine regulatory body has “approved the Abbreviated New Drug Application (ANDA) for Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg, 100 mg/12.5 mg, and 100 mg/25 mg", the Pune-headquartered drugmaker said in a release.
The new drug is “bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Hyzaar Tablets of Organon LLC", it added. Losartan potassium and hydrochlorothiazide tablets are indicated for the treatment of hypertension to lower blood pressure and to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, the company further noted.
Exciting news! Mint is now on WhatsApp Channels. Subscribe today by clicking the link and stay updated with the latest financial insights!" Click here! The current annual US market for Losartan and Hydrochlorothiazide tablets is approximately $73 million, according to a July 2023 report released by American pharmaceutical firm IQVIA and IMS Health.
With the fresh nod from the USFDA, Granules now have a total of 60 ANDA approvals from US drug regulator, including 58 final approvals and 2 tentative approvals. In the quarter ending June 2023, Granules had reported an on-year slump of 62.4 percent in its net profit, which came in at ₹ ₹47.9 crore.
The company's revenue from operations declined by 3.3 percent on-year to ₹985.5 crore, whereas, the earnings before interest, taxes, depreciation and ammortisation (EBITDA) fell by 35.3 percent to ₹136.8 crore. The margin of
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