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BUSINESS

Granules India Receives USFDA Approval for Hypertension Drug

The inspection occurred from 26th August to 6th September.

Granules India on 3 October announced that it had received approval from USFDA (the US Food and Drug Administration) for its Hypertension treatment tablets.

The USFDA has approved the company’s abbreviated new drug application for Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg, 100 mg/12.5 mg, and 100 mg/25 mg.

The tablets are therapeutically equivalent and bioequivalent to the RLD (reference listed drug) Hyzaar Tablets of OrganonLLC.

Losartan potassium and hydrochlorothiazide tablets are used 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 has a total of 60 abbreviated new drug application approvals from the USFDA, of which 58 are final approvals and 2 are tentative approvals.

In September, in the inaugural review by MSCI, the company was awarded a “BB” rating in MSCI ESG rating with an industry-adjusted score of 4.1.

The company’s Bonthapally facility in Telangana has received approval from the Brazilian regulator for compliance with the guidelines of good manufacturing practices.

The company is engaged in the production of pharmaceutical raw materials and specialises in finished dosage and pharmaceutical formulation intermediates, as well as active pharma ingredients.

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