Days after Sun Pharma’s Halol plant was listed on import alert by the US Food and Drug Administration (FDA), the company said it has received a warning letter from regulator summarizing violations at the manufacturing plant in Gujarat.
“We now wish to inform you that the Company has received Warning Letter from USFDA for the Halol facility. The Warning Letter summarizes violations with respect to Current Good Manufacturing Practice (cGMP) regulations. USFDA shall make public the contents of the Warning Letter in due course,” the pharma company said in an exchange filing.
The USFDA last week listed the Halol facility in Gujarat under import alert, with products manufactured at the unit now subject to refusal of admission in the US market.
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The decision from the FDA was after an inspection of the facility by the USFDA from April 26 to May 9, 2022.
The Import Alert implies inter alia, that all future shipments of products manufactured at this facility are subject to refusal of admission to the US market until the facility becomes compliant with cGMP standards, Sun Pharma said in statement last week.
Sun Pharma has said that the supplies to the US market from the Halol facility accounted for approximately three percent of firm’s consolidated revenues.
“The Company continues to cooperate with the USFDA and will undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the Company’s remedial action,” it added.
The USFDA has excluded 14 products from this import alert subject to certain conditions.
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