Ajanta Pharma’s, zolmitriptan receives US FDA approval

Ajanta Pharma Limited, a Rs.1,728 crore plus Mumbai-based specialty pharmaceutical formulation company, has announced the receipt of final approval for zolmitriptan tablets (2.5mg, 5mg) from the US Food and Drug Administration (FDA). Zolmitriptan is used in the acute treatment of migraine and is a bioequivalent generic Ajanta-Pharmaversion of Zomig of AstraZeneca Group.

Zolmitriptan tablets is part of an ever-growing portfolio of products that Ajanta has developed for the US market. To date, the US FDA has granted the company 9 ANDA final approvals and 2 tentative approvals. Additional 15 ANDAs are under review with the FDA.


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