Alembic Pharmaceuticals Limited has secured final regulatory clearance from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dapsone Gel, 5%. This topical formulation is therapeutically equivalent to Almirall, LLC’s reference listed drug, Aczone Gel, 5%, and is indicated for the treatment of acne vulgaris.
This latest milestone underscores Alembic’s ongoing commitment to expanding its global generic portfolio. With this addition, the company’s regulatory track record rises to a cumulative total of 244 ANDA approvals from the USFDA, consisting of 224 final nods and 20 tentative nods.
Operating as a vertically integrated research and development enterprise since 1907, Alembic has established itself as a cornerstone of the Indian healthcare sector and a major player in international markets. The company relies on a robust network of state-of-the-art manufacturing and research hubs vetted by international regulatory agencies, alongside a dedicated field force of over 5,500 professionals who deliver high-quality, trusted generic treatments to medical practitioners and patients worldwide.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
