Zydus Lifesciences Receives USFDA Warning Letter Over Baddi Facility's Purified Talc Usage
Zydus Lifesciences Limited has received a Warning Letter from the United States Food and Drug Administration (USFDA) concerning its formulation manufacturing facility located in Baddi, Himachal Pradesh.The Warning Letter pertains to technical observations related to the use of purified talc at the facility, noting that the material did not meet current United States Pharmacopeia (USP) requirements. The company clarified that the communication was issued in response to a request for records and was not related to an onsite inspection by the USFDA.
Zydus Lifesciences stated that it believes this Warning Letter will not affect its current operations or product supplies emanating from the Baddi site.
The Baddi facility had previously been subjected to an on-site inspection by the USFDA in August 2025. Following this inspection, Zydus received the Establishment Inspection Report (EIR) in October 2025, which classified the final compliance status as Voluntary Action Indicated (VAI).
The company committed to collaborating transparently and working with the USFDA to complete all necessary remediation steps at the earliest possible time and within the stipulated timelines.
ZYDUSLIFE Stock Price Movement
Zydus Lifesciences Limited stock is slipping by 1.60% in live trading as of 10:30 AM, currently registering at ₹1061. The equity has seen a total traded volume of 364,712 shares so far today.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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