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Zydus Lifesciences shares declined more than 2% in morning trade on June 3 after the company informed exchanges that it had received a Warning Letter from the United States Food and Drug Administration (USFDA) concerning its formulation manufacturing facility located in Baddi, Himachal Pradesh.
At 10:43 AM, the stock was trading under pressure as investors reacted to the regulatory development. The company clarified that the Warning Letter was issued following a request for records under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act and was not linked to any recent on-site inspection conducted by the USFDA.
According to the filing, the regulator’s observations relate to the use of purified talc that did not meet the current United States Pharmacopeia (USP) requirements. Zydus stated that the observations were identified through a review of records submitted to the USFDA and are technical in nature.
The pharmaceutical company emphasized that the Warning Letter is not expected to have any material impact on operations at the Baddi facility. Manufacturing activities continue as normal, and there has been no disruption to customer supplies or product distribution from the site.
The Baddi manufacturing facility was last inspected by the USFDA in August 2025. Following that inspection, the company received an Establishment Inspection Report (EIR) in October 2025, and the facility was classified under the Voluntary Action Indicated (VAI) category. This classification generally indicates that while certain observations were made during the inspection, they did not require immediate regulatory enforcement action.
Zydus Lifesciences further stated that it is committed to addressing the observations highlighted in the Warning Letter and will continue to work closely with the USFDA. The company plans to complete the necessary remediation measures and submit a detailed response within the timelines prescribed by the regulator.
Despite the company's assurance that operations remain unaffected, investors remained cautious, leading to selling pressure in the stock during the session.
Zydus Lifesciences share price Performance
As of 10:43 AM, Zydus Lifesciences shares were trading over 2% lower. Key trading data for the session is as follows:
- Open Price: Rs 1,078.10
- Previous Close: Rs 1,078.30
- Day's High: Rs 1,091.10
- Day's Low: Rs 1,048.90
- 52-Week High: Rs 1,115.50
- 52-Week Low: Rs 835.50
- Live Volume: 5,40,344 shares
Market participants will closely monitor the company's response to the USFDA and any further regulatory developments related to the Baddi facility.
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