Sun Pharmaceutical Industries said its Halol, Gujarat facility has received warning letter from the USFDA regarding the inspection conducted from 26 April 2022 to 9 May 2022.
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, said the pharma company.Earlier, on 8 December 2022, the drug maker had intimated that the US FDA placed the Halol, Gujarat facility under import alert.
The import alert implied 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 current good manufacturing practice (cGMP) standards. The USFDA had excluded 14 products from this import alert subject to certain conditions.
Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.
The pharma major's consolidated net profit rose 10.51% to Rs 2,262.22 crore on 13.11% increase in revenue from operations to Rs 10,809.19 crore in Q2 FY23 over Q2 FY22.
The scrip declined 0.83% to settle at Rs 993.25 on Friday.
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