Alembic Pharmaceuticals received final approval from the US Food and Drug Administration (USFDA) for Dapsone Gel, 5%, strengthening its dermatology portfolio in the US market. The approval covers the company's Abbreviated New Drug Application (ANDA) for the product, which is indicated for the topical treatment of acne vulgaris. This regulatory milestone allows Alembic to market a generic version of the product, expanding its presence in the American pharmaceutical sector.

The approved ANDA is therapeutically equivalent to the reference listed drug product Aczone Gel, 5%, marketed by Almirall, LLC. Dapsone Gel serves as a treatment option for acne vulgaris, a common skin condition. The approval follows the company's submission and review process, confirming the product's bioequivalence to the branded reference.

Regulatory Approvals

The USFDA approval adds to Alembic's growing list of cleared generic products. The company has now secured a cumulative total of 244 ANDA approvals from the USFDA. This tally includes 224 final approvals and 20 tentative approvals, demonstrating the company's consistent capability in navigating the complex regulatory landscape for generic drugs.

Alembic Pharmaceuticals Limited, established in 1907, operates as a vertically integrated research and development pharmaceutical company. Headquartered in Vadodara, India, the firm manufactures and markets generic pharmaceutical products globally. Its research and manufacturing facilities are approved by regulatory authorities in several developed countries, including the USFDA. The company is recognized as a leader in branded generics in India, supported by a field force of over 5,500 personnel.

Alembic Pharmaceuticals received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, on June 26, 2026. The approval allows the company to market a generic version of Hoffmann-La Roche Inc's Tamiflu Oral Suspension, targeting an estimated annual US market size of $27 million for the twelve months ending March 2026. This regulatory milestone strengthens Alembic's portfolio in the US generic pharmaceutical market.

The approved product is therapeutically equivalent to the reference listed drug Tamiflu Oral Suspension, 6 mg/mL. Oseltamivir Phosphate is an influenza neuraminidase inhibitor indicated for the treatment of acute, uncomplicated influenza A and B in patients two weeks of age and older who have been symptomatic for no more than 48 hours. It is also indicated for the prophylaxis of influenza A and B in patients one year and older.

Product Details and Indications

The drug is specifically used for the treatment of acute, uncomplicated influenza in pediatric and adult patients, provided treatment starts within 48 hours of symptom onset. Additionally, it serves as a prophylactic measure for influenza A and B in patients aged one year and older. Key product details are outlined below:

Regulatory Approvals

Alembic Pharmaceuticals now holds a cumulative total of 243 ANDA approvals from the USFDA. This tally includes 223 final approvals and 20 tentative approvals. The company continues to expand its presence in the US market through the addition of new generic products to its portfolio.