Zydus Lifesciences on Wednesday said it has received a warning letter from the United States Food and Drug Administration (USFDA) for its formulation manufacturing facility at Baddi in Himachal Pradesh, but asserted that the communication will not impact current operations or supplies from the site.
“The communication references technical observations regarding the use of purified talc that did not meet the current United States Pharmacopeia (USP) requirements,” Zydus Lifesciences said in its exchange filing.
In a regulatory filing to the exchanges, the drugmaker said the warning letter was issued in response to a request for records under Section 704(a)(4) of the US Federal Food, Drug, and Cosmetic Act and does not relate to any on-site inspection by the regulator. The observations cited are technical in nature and pertain to the use of purified talc that did not meet current United States Pharmacopeia (USP) requirements, the company said .
Zydus added that the Baddi facility was last inspected by the USFDA in August 2025, following which it received the Establishment Inspection Report (EIR) in October 2025 with the final compliance status classified as Voluntary Action Indicated (VAI) .
“The company is committed to working collaboratively and transparently with the USFDA to complete the necessary remediation steps at the earliest and respond within the stipulated timelines,” Zydus said in the filing.
