Zydus Lifesciences gets USFDA’s tentative approval for Budesonide capsules

05 Nov 2025 Evaluate

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 8 years of age and older. Budesonide capsules will be produced at is 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.

Zydus Lifesciences (formerly known as Cadila Healthcare), a company limited by shares, incorporated and domiciled in India, operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.


Zydus Lifesciences Share Price

931.45 -3.75 (-0.40%)
05-Dec-2025 16:59 View Price Chart
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