Zydus Lifesciences Limited has informed the Exchange regarding a press release dated November 04, 2025, titled "Zydus receives tentative approval from USFDA for Budesonide delayed release capsules, 4 mg".
ZYDUSLIFE · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
Awaiting price reaction for this filing.
Zydus Lifesciences has received tentative approval from the USFDA to market generic Budesonide delayed-release capsules in 4 mg strength, the brand version of which is Tarpeyo. Budesonide is used to treat mild to moderate Crohn's disease in adults and children aged 8 and above, and will be manufactured at Zydus' SEZ-II facility. With this addition, Zydus now holds 425 total USFDA approvals and has filed 487 ANDAs cumulatively since FY 2003-04 (as on 30 September 2025). A tentative approval means the generic is cleared on safety and efficacy but cannot be launched commercially until existing patent or exclusivity barriers on the reference brand expire.
Tentative approvals do not generate immediate revenue but strengthen Zydus' generic pipeline and position it for future market entry once exclusivity on Tarpeyo lapses. The steady addition of ANDAs reflects an active US business, which is a key growth driver for the stock.