Zydus bags tentative USFDA nod for Crohn's disease drug Budesonide delayed release

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-11-04 10:20 GMT   |   Update On 2025-11-04 10:21 GMT
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Ahmedabad: Zydus Lifesciences Limited 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 8 years of age and older.
Budesonide capsules will be produced at is Zydus Pharmaceuticals Ltd, SEZ-II.
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The group now has 425 approvals and has so far filed 487 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs.



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