USFDA Approves Alembic Pharma's Generic Drug for Treating Skin Disorders
- Alembic Pharmaceuticals received final approval from USFDA for its Betamethasone Valerate Foam, 0.12%.
- The company has now received a total of 213 ANDA approvals from the USFDA, including 185 final approvals and 28 tentative approvals.
Alembic Pharmaceuticals Limited announced on Tuesday that it has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) Betamethasone Valerate Foam, 0.12%.
The company stated that the approved ANDA is therapeutically equivalent to the reference drug, Luxiq Foam, 0.12%, from Norvium Bioscience, LLC.
Betamethasone valerate foam, 0.12%, is a medium potency topical corticosteroid used to relieve inflammation and itching from corticosteroid-responsive scalp dermatoses, the company stated.
Alembic Pharmaceuticals Limited, established in 1907, is a leading research and development company based in India. As a publicly traded company, it produces and sells generic pharmaceutical products worldwide.
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The pharmaceutical company has received a total of 213 ANDA approvals from the USFDA, including 185 final approvals and 28 tentative approvals.
Moreover, Alembic Pharmaceuticals reported an 11.5% increase in profit after tax (PAT) for the April-June quarter of FY 2024-25, reaching Rs 134 crore, largely due to strong sales in the US market. Their revenue from operations grew by 4.4% year-on-year to Rs 1,563.8 crore in the June quarter.
However, compared to the previous quarter, revenue went up by 2.8%, but PAT dropped by 24.5%. The Earnings before interest, tax, depreciation, and amortisation (Ebitda) margin increased by 14% year-on-year to Rs 239 crore.
Edited by Harshajit Sarmah
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