Alembic Pharmaceuticals Receives USFDA Final Approval for Dapsone Gel, 5%
Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Dapsone Gel, 5%. The company stated that the approved ANDA is therapeutically equivalent to Aczone Gel, 5%, a reference listed drug product from Almirall, LLC.Dapsone Gel is indicated for the topical treatment of acne vulgaris.
The final approval marks a significant milestone for Alembic in the global pharmaceutical market. The company reported that it holds a cumulative total of 244 ANDA approvals from USFDA, comprising 224 final approvals and 20 tentative approvals.
Key details regarding Alembic Pharmaceuticals' regulatory achievements are summarized below:
| Metric | Value |
|---|---|
| Total Cumulative ANDA Approvals | 244 |
| Final ANDA Approvals | 224 |
| Tentative ANDA Approvals | 20 |
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company established in 1907. Headquartered in India, the publicly listed company manufactures and markets generic pharmaceutical products globally.
Alembic operates state of the art research and manufacturing facilities that have been approved by regulatory authorities across many developed countries, including the USFDA. As a leader in branded generics in India, Alembic's brands are marketed through a field force exceeding 5,500 and are recognized widely by doctors and patients.
APLLTD Stock Price Movement
Shares of Alembic Pharmaceuticals Limited slipped by 1.5% to close on Thursday at ₹771.50. The equity saw a total traded volume of 21,774 shares during the session.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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