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Ajanta Pharma Gets USFDA Approval Of Zolmitriptan Tablets

USFDA has granted Ajanta Pharma 9 ANDA final approvals and two tentative approvals. Additional 15 ANDAs are under review with the American regulator

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Ajanta Pharma has received final approval from the US Food and Drug Administration (FDA) to manufacture and market Zolmitriptan tablets, a drug used to treat migraine.

"This product is expected to be launched within two months from now," a company source said.

Zolmitriptan is a bioequivalent generic version of Zomig ® 1 and is a part of an ever-growing portfolio of products that Ajanta has developed for the US market.

USFDA has granted Ajanta Pharma 9 ANDA final approvals and two tentative approvals. Additional 15 ANDAs are under review with the FDA.

Ajanta Pharma is a specialty pharmaceutical formulation company with global headquarters in Mumbai. Over 6,000 employees are engaged in developing, manufacturing and marketing of quality finished dosages across 30 countries.