Granules India Receives USFDA Approval for Hypertension Drug Equivalent to Hyzaar Tablets

3 Oct 2023 , 03:40 PM

Granules India gains approval from USFDA for its new generic drug, a counterpart to a hypertension treatment drug The approved drug is a generic equivalent of Hyzaar Tablets by Organon LLC, aimed at treating hypertension and reducing stroke risk.

Losartan Potassium and Hydrochlorothiazide Tablets USP in strengths of 50 mg/12.5 mg, 100 mg/12.5 mg, and 100 mg/25 mg received the green light from the US regulatory body. The annual US market for Losartan and Hydrochlorothiazide tablets is estimated at about $73 million as per IQVIA and IMS Health’s July 2023 report.

This approval marks Granules India’s 60th ANDA approval from the USFDA, including 58 final approvals and 2 tentative approvals. In Q2 of 2023, Granules reported a significant YoY decline in net profit by 62.4%, standing at Rs 47.9 crore, while revenue from operations decreased by 3.3% to Rs 985.5 crore.

Earnings before interest, taxes, depreciation, and ammortisation (EBITDA) witnessed a 35.3% YoY fall to Rs 136.8 crore, causing a shrink in EBITDA margin to 13.9%, down by 680 basis points compared to the previous year.

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