Zydus Cadila gets USFDA nod for Mesalamine ER capsules

It is indicated for the maintenance of remission of ulcerative colitis in adults.

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USFDA Drug product Approval
USFDA Approval

Last Updated on December 31, 2023 by The Health Master

Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market mesalamine extended-release capsules in the strength of 0.375 g.

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.

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