India, June 3 -- Zydus Lifesciences has informed exchanges that it has received a Warning Letter from the US Food and Drug Administration (USFDA) related to its formulation manufacturing facility in Baddi, Himachal Pradesh.
The Warning Letter was issued following a request for records under Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act and is not linked to any recent on-site inspection by the USFDA. The communication highlights technical observations concerning the use of purified talc that did not meet current United States Pharmacopeia (USP) requirements.
The company stated that the Warning Letter is not expected to impact ongoing operations or product supplies from the Baddi facility. Notably, the plant underwent a USFD...