Zydus receives tentative USFDA approval for Budesonide capsules

Zydus Lifesciences Limited announced on November 4, 2025, that it has received tentative approval from the United States Food and Drug Administration (USFDA) for its Budesonide delayed-release capsules, 4 mg. This formulation is indicated for the treatment of mild to moderate active Crohn's disease affecting the ileum and/or ascending colon in adults and children aged 8 years and older. The Budesonide capsules will be manufactured at Zydus Pharmaceuticals Ltd, SEZ-II.

This latest approval marks a notable addition to Zydus's product pipeline. The group now holds a total of 425 approvals and has filed 487 Abbreviated New Drug Applications (ANDAs) since initiating its filing process in fiscal year 2003-04. The company continues to expand its presence in the pharmaceutical market with these regulatory achievements.