Zydus Cadila receives final approval from USFDA for Mesalamine Extended-Release Capsules

Zydus Cadila
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Zydus Cadila (File/Photo)

Highlights

Drug major Zydus Cadila on Friday, August 13, 2021, announced that it has received final approval from the US drug regulator to market Mesalamine Extended-Release Capsules in the strength of 0.375 g.

Drug major Zydus Cadila on Friday, August 13, 2021, announced that it has received final approval from the US drug regulator to market Mesalamine Extended-Release Capsules in the strength of 0.375 g.

Teg company in a regulatory filing said, "It has received USFDA to market Mesalamine Extended-Release Capsules in the strength of 0.375 g, (US RLD: Apriso)."

Mesalamine Extended-Release capsules are indicated for the maintenance of remission of ulcerative colitis in adults. The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad.

The group now has 320 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Cadila Healthcare closed 2.57 per cent higher at Rs 558 on NSE. Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs nearly 25000 people worldwide and is dedicated to creating healthier communities globally.

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