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Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Dapsone Gel, 5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Aczone Gel, 5%, of Almirall, LLC.
Dapsone Gel is indicated for the topical treatment of acne vulgaris. Refer label for a detailed indication. Alembic has a cumulative total of 244 ANDA approvals (224 final approvals and 20 tentative approvals) from USFDA.
Aurobindo Pharma announced that the United States Food and Drug Administration (US FDA) conducted an inspection at Auroactive Pharma (a wholly owned subsidiary of the Company), which manufactures Active Pharmaceutical Ingredients (API) & Pharmaceutical Formulation Intermediates, situated at Sy Nos 231, 285 to 291, Sancham Village, Ranasthalam Mandal, Srikakulam District, 523 409, Andhra Pradesh, from 22 June 2026, to 26 June 2026.
The inspection concluded with 2 observations and will be responded to within the stipulated time.
The contract shall remain in force for a period of five years with effect from 01 July 2026. The estimated value of the contract is Rs 406.43 crore.
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