News Stocks Zydus Lifesciences USFDA Inspection at Ankleswar Plant Concludes with 3 ObservationsZydus Lifesciences USFDA Inspection at Ankleswar Plant Concludes with 3 Observations
Zydus Lifesciences Limited completed a USFDA inspection at its Unit-2 manufacturing plant in Ankleswar, Gujarat, from January 19-23, 2026. The inspection concluded with 3 observations, with no data integrity related issues identified. The company has committed to working closely with the USFDA to address the observations expeditiously and made this disclosure under SEBI Regulation 30 requirements.
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Zydus Lifesciences Limited has announced the completion of a United States Food and Drug Administration (USFDA) inspection at its Unit-2 manufacturing plant located in Ankleswar, Gujarat. The pharmaceutical company disclosed this development through a press release dated January 23, 2026, as part of its regulatory compliance obligations.
Inspection Details and Timeline
The USFDA inspection was conducted over a five-day period from January 19 to January 23, 2026. The regulatory review focused on the company's Unit-2 manufacturing facility at Ankleswar, which is part of Zydus Lifesciences' manufacturing operations in Gujarat.
| Parameter: | Details |
|---|---|
| Inspection Duration: | January 19-23, 2026 |
| Facility: | Unit-2 manufacturing plant |
| Location: | Ankleswar, Gujarat |
| Total Observations: | 3 |
| Data Integrity Issues: | None |
Inspection Outcome
The inspection concluded with 3 observations from the USFDA. Significantly, the company emphasized that there were no data integrity related observations during the inspection process. Data integrity issues are typically considered more serious regulatory concerns, and their absence suggests the inspection focused on other operational or compliance aspects.
Company Response and Next Steps
Zydus Lifesciences has stated its commitment to addressing the observations received during the inspection. The company indicated it will work closely with the USFDA to resolve the identified issues expeditiously. This collaborative approach demonstrates the company's focus on maintaining regulatory compliance and addressing any concerns raised by the regulatory authority.
Regulatory Disclosure
The announcement was made pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. This regulation requires listed companies to disclose material events and information that could impact investor decisions, including regulatory inspections and their outcomes.
The disclosure was communicated to both the BSE Limited and the National Stock Exchange of India Limited on January 23, 2026, ensuring transparency with investors and market participants regarding this regulatory development.
Historical Stock Returns for Zydus Life Science
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| -0.37% | -0.20% | -3.94% | -7.81% | -9.86% | +91.53% |
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