Alembic Pharmaceuticals Limited has received final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dapsone Gel, 5%, strengthening the company’s portfolio of dermatology products in the US market. The approved product is therapeutically equivalent to Aczone Gel, 5%, marketed by Almirall LLC, and is indicated for the topical treatment of acne vulgaris. The approval enables Alembic to market its generic formulation in the United States, providing patients and healthcare providers with an additional treatment option for one of the most common skin disorders.
Dapsone Gel is widely prescribed as a topical therapy for acne vulgaris, helping reduce inflammatory lesions associated with the condition. The product offers an alternative to branded treatment while maintaining the same standards of quality, safety and efficacy required by the USFDA. Healthcare professionals are advised to refer to the approved prescribing information for complete details regarding indications, dosage and administration.
The latest approval further expands Alembic’s presence in the highly regulated US pharmaceutical market, reflecting the company’s continued focus on developing and commercialising high-quality generic medicines. It also reinforces Alembic’s long-term strategy of building a diversified product portfolio across multiple therapeutic segments while addressing growing demand for affordable healthcare solutions.
With this approval, Alembic has now received a cumulative total of 244 ANDA approvals from the USFDA, comprising 224 final approvals and 20 tentative approvals. The milestone highlights the company’s consistent investment in product development, regulatory compliance and manufacturing excellence, enabling it to compete successfully in one of the world’s most demanding pharmaceutical markets.
Founded in 1907, Alembic Pharmaceuticals is among India’s established pharmaceutical manufacturers with more than a century of experience in research, development and the production of medicines. The company operates as a vertically integrated pharmaceutical business, managing activities from research and formulation development through manufacturing and global marketing.
Headquartered in India, Alembic supplies a broad portfolio of generic pharmaceutical products to international markets. Its advanced research and manufacturing facilities are approved by leading global regulatory agencies, including the USFDA, supporting the company’s commitment to maintaining international quality standards across its operations.
In the domestic market, Alembic remains one of India’s leading branded generic pharmaceutical companies. Its portfolio includes a wide range of well-recognised brands marketed through a nationwide field force of more than 5,500 professionals, serving healthcare providers and patients across the country.
The latest USFDA approval underscores Alembic Pharmaceuticals’ commitment to expanding patient access to affordable, high-quality medicines while strengthening its position in global pharmaceutical markets through continuous innovation and regulatory excellence.
