Alembic Pharmaceuticals Receives US FDA Approval for Generic Dapsone Gel 5% for Acne Treatment

Alembic Expands Its US Generic Portfolio

Alembic Pharmaceuticals Limited has received final approval from the United States Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Dapsone Gel, 5%.
The approval allows the company to market its generic version of the product in the United States, further strengthening its growing portfolio of FDA-approved generic medicines.

Generic Version of Aczone Gel Approved

Alembic’s Dapsone Gel, 5% has been approved as therapeutically equivalent to the reference listed drug (RLD), Aczone Gel, 5%, marketed by Almirall, LLC.
The product is indicated for the topical treatment of acne vulgaris, a common skin condition that affects millions of adolescents and adults worldwide. The approval offers healthcare providers and patients another generic treatment option for acne management.

Milestone Adds to Alembic’s FDA Approval Count

With this latest approval, Alembic has further expanded its presence in the US pharmaceutical market.
The company now holds a cumulative total of 244 ANDA approvals from the US FDA. This includes 224 final approvals and 20 tentative approvals, highlighting Alembic’s continued focus on

strengthening its generic product pipeline.

Strengthening Presence in the US Generic Market
The latest FDA approval reflects Alembic’s ongoing strategy of expanding its portfolio of affordable generic medicines across multiple therapeutic categories.
The US remains one of the company's key international markets, where regulatory approvals play an important role in increasing product availability and improving patient access to cost-effective treatment options.

About Alembic Pharmaceuticals

Headquartered in India, Alembic Pharmaceuticals is a publicly listed pharmaceutical company engaged in the development, manufacturing, and marketing of generic medicines across global markets.
The company operates advanced research and manufacturing facilities that are approved by several international regulatory authorities, including the US FDA. Through continuous investments in research, manufacturing, and regulatory compliance, Alembic continues to expand its footprint in regulated pharmaceutical markets worldwide.

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