Zydus Cadila receives final approval from USFDA to market Entecavir Tablets

27 Jun 2017 Evaluate

Zydus Cadila has received the final approval from the United States Food & Drug Administration (USFDA) to market Entecavir Tablets in the strengths of 0.5 mg and 1 mg. The drug is used in the treatment of Hepatitis B Virus infection and will be produced at the group’s formulations manufacturing facility at the Pharma SEZ in Ahmedabad. The estimated sale for Entecavir tablets is $166.3 million, as per IMS MAT April 2017.

The group now has more than 120 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies.



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