Alembic Pharmaceuticals receives USFDA Final Approval for Dabigatran Etexilate Capsules 110 mg

On August 13, 2024, Alembic Pharmaceuticals announced it had received final approval from the US FDA for its Dabigatran Etexilate Capsules, 110 mg.

This approval allows Alembic to market a generic version of Boehringer Ingelheim’s Pradaxa Capsules, 110 mg. These capsules are used to reduce the risk of pulmonary embolism and deep vein thrombosis after hip replacement surgery.

With this latest approval, Alembic now has 211 ANDA approvals from the US FDA, including 183 final and 28 tentative approvals.

In their recent press release on August 7, 2024, Alembic Pharmaceuticals announced that it had received final approval from the US FDA for its Acitretin Capsules USP in 10 mg, 17.5 mg, and 25 mg doses. These capsules are a generic version of Stiefel Laboratories’ Soriatane Capsules and are used to treat severe psoriasis in adults. The market for these capsules is estimated to be around $21 million for the year ending June 2024, according to IQVIA.

Financial Highlights

For the April-June quarter of FY25, the company achieved good growth in both revenue and profit compared to the previous year. Revenue from operations reached ₹1,562 crore, marking a 5% increase from ₹1,486 crore in the same quarter of FY24. In Q1 FY25, the company’s net profit increased by 10% year-on-year to ₹131 crore, up from ₹119 crore in the same quarter last year. However, it declined by 21% compared to ₹166 crore in Q4 FY24. The company’s EBITDA rose 14% to ₹239 crore.

About Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited founded in 1907 and based in India. It is publicly listed and specialises in developing and selling generic drugs globally. Alembic has modern research and manufacturing facilities that meet the standards of regulatory authorities in many advanced countries, including the US FDA. The company is a major player in the branded generics market in India, with its products widely recognised by doctors and patients. Its marketing team, which consists of over 5,000 members, helps promote these brands effectively.

On August 13, 2024, Alembic Pharmaceuticals Limited’s share price opened at ₹1,117.35, touching the day’s high at ₹1,129.95, as of 12:10 PM on the NSE.

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