Zydus Under USFDA Lens as Baddi Plant Receives Warning Letter
New Delhi: Zydus Lifesciences has informed the stock exchanges that it has received a Warning Letter from the United States Food and Drug Administration (USFDA) pertaining to its formulation manufacturing facility located at Baddi, Himachal Pradesh.
According to the company, the Warning Letter was issued in response to a request for records under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act. Zydus clarified that the regulatory action is not related to any on-site inspection conducted by the USFDA at the facility.
The company stated that the communication contains technical observations regarding the use of purified talc that did not meet the current United States Pharmacopeia (USP) requirements. However, Zydus said it believes that the Warning Letter will not have any impact on current operations or product supplies from the Baddi manufacturing site.
Zydus further highlighted that the Baddi facility was last inspected by the USFDA in August 2025. Following completion of that inspection, the company received the Establishment Inspection Report (EIR) in October 2025, with the facility being classified under the Voluntary Action Indicated (VAI) category.
The company said the receipt of the EIR and VAI status reflected the outcome of the most recent on-site USFDA inspection at the facility, while the current Warning Letter relates specifically to records requested by the agency and not to inspection findings.
Zydus Lifesciences stated that it remains committed to working collaboratively and transparently with the USFDA to undertake the necessary remediation measures at the earliest and provide its response within the stipulated timelines.
The company has assured stakeholders that it will continue to engage with the USFDA and address the observations raised in the Warning Letter while maintaining uninterrupted operations at the facility.
