Zydus Lifesciences has received tentative approval from the US Food and Drug Administration (USFDA) for Budesonide delayed-release capsules, 4 mg. The capsules are indicated for treating mild to moderate Crohn’s disease involving the ileum and/or ascending colon in adults and children aged 8 years and older. This approval marks another milestone for Zydus, which now has 425 approvals and 487 ANDAs filed since FY 2003-04.
USFDA Nod for Budesonide Capsules
Zydus Lifesciences Limited has secured tentative approval from the United States Food and Drug Administration (USFDA) for its Budesonide delayed-release capsules, 4 mg (USRLD: Tarpeyo Capsules, 4 mg). The announcement was officially released on November 4, 2025.
Indication and Production
The Budesonide capsules are designed for the treatment of mild to moderate active Crohn’s disease, specifically targeting the ileum and/or the ascending colon in adult and pediatric patients (8 years and older). The production of these capsules will take place at Zydus Pharmaceuticals Ltd, SEZ-II.
Growing Portfolio
As of September 30, 2025, Zydus Lifesciences now holds 425 approvals and has filed 487 Abbreviated New Drug Applications (ANDAs) since the commencement of its filing process in the financial year 2003-04. This approval further strengthens the company’s presence in the pharmaceutical market.
Source: BSE
