Alembic Pharmaceuticals Secures USFDA Approval for Betamethasone Valerate Foam

Alembic Pharmaceuticals Limited has informed the stock exchanges that the company received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Betamethasone Valerate Foam, 0.12%.

This approval marks a pivotal step for Alembic Pharmaceuticals, as the product is therapeutically equivalent to Luxiq Foam, 0.12%, developed by Norvium Bioscience, LLC. Betamethasone valerate foam is a medium-potency topical corticosteroid used for treating inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the scalp.

With this approval, Alembic Pharmaceuticals now holds a total of 213 ANDA approvals from the USFDA, including 185 final and 28 tentative approvals.

Earlier in August 2024, Alembic Pharmaceuticals also secured final approval for its ANDA for Dabigatran Etexilate Capsules, 110 mg. This drug is therapeutically equivalent to Pradaxa Capsules, 110 mg, produced by Boehringer Ingelheim Pharmaceuticals, Inc. Dabigatran Etexilate Capsules are used for the prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery.

Meanwhile, Alembic Pharmaceuticals reported its consolidated financial results for the first quarter ending June 30, 2024. The company’s net sales increased by 5% to ₹1,562 crore. Net profit saw a significant rise of 12%, reaching ₹135 crore. The company also reported an EBITDA increase of 14%, totalling ₹239 crore.

About Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals is engaged in the development, manufacturing, and marketing of pharmaceutical products, such as formulations and active pharmaceutical ingredients. Founded in 1907, Alembic Pharmaceuticals Limited is a vertically integrated, research-driven pharmaceutical company headquartered in India. As a leading player in branded generics in India, Alembic’s products are widely recognised by both doctors and patients, supported by a marketing team of over 5,000 professionals.

On August 26, 2024, the share price of Alembic Pharmaceuticals Ltd opened at ₹1,134.80, touching the day’s high at ₹1,157.90, as of 10:30 AM on the NSE.

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