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...