Zydus Cadila has received the final approval from the United States Food & Drug Administration (USFDA) for Mesalamine Delayed-Release Tablets in the strength of 800 mg. The drug will be manufactured at the group's formulation manufacturing facility at Moraiya.
The group has received 27 final ANDA approvals from the USFDA and 2 tentative ANDA approvals since January 2017. The group now has more than 130 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.