Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Budesonide delayed-release capsules, 4 mg (USRLD: Tarpeyo Capsules, 4 mg).

Budesonide is indicated for mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in adults and children eight years of age and older. The capsules will be produced at Zydus Pharmaceuticals, SEZ-II.

The group now has 425 approvals and has so far filed 487 ANDAs since the commencement of the filing process in FY 2003-04.