Zydus Lifesciences Limited
Ahmedabad, India
Works in Dermatology · Genetic & rare · GI & liver · Hematology · Immunology · Infectious disease · Metabolic & endocrine · Neurology · Oncology · Renal & urogenital · Respiratory · Women's health
Zydus Lifesciences Limited is a clinical trial sponsor based in Ahmedabad, India. It has 1 active clinical trial with 1,004 planned participants, across 12 therapeutic areas. Since 2021 it has completed 11 trials and stopped 1 early. Its FDA record on file shows 1 inspection and 1 warning letter.
Trial track record · since 2021
FDA record
Recent FDA actions
Pipeline · 1 active trial
| Stage | Trial | Status |
|---|---|---|
On the market
3 approved drug applications with a product on the market.
Questions about Zydus Lifesciences Limited
Yes. FDA has published 1 warning letter naming Zydus Lifesciences Limited; the latest was posted on 2026-06-09. Each letter links to FDA's own posting.
FDA has posted 1 inspection classification naming Zydus Lifesciences Limited. The latest inspection ended on 2026-05-05 and was classified VAI (voluntary action indicated). FDA posts a classification after its review, often months after the inspection ended.
Zydus Lifesciences Limited is lead sponsor of 1 active clinical trial on ClinicalTrials.gov, with 1,004 planned participants, in Dermatology, Genetic & rare, GI & liver, Hematology and other areas. Since 2021 it has completed 11 trials and stopped 1 early.
Zydus Lifesciences Limited is based in Ahmedabad, India. The address is the one on its FDA records or ClinicalTrials.gov registrations, which name the establishment or the registrant, not always the group's head office.
From public sources only: ClinicalTrials.gov for trials, FDA's Data Dashboard, warning-letter listing and enforcement reports for the FDA record, and SEC filings for financials. Approve Suite is not affiliated with Zydus Lifesciences Limited; every record links to the source, and nothing here is advice.
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Trial counts are as the sponsor reported them to ClinicalTrials.gov, for trials changed since 2021; latest update 2025-01-22.
The FDA record counts inspection classifications, warning letters and recalls FDA has published that name this company. Compare it with the industry in the free CDMO FDA inspection lookup.
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