USFDA lists Sun Pharma’s Halol unit under ‘import alert’
According to a statement from the pharmaceutical company to the stock exchanges, the Import Alert implies 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.
New Delhi [India], December 8 (ANI): The United States Food and Drug Administration on Thursday listed the Halol facility in Gujarat of Sun Pharmaceuticals under Import Alert.
According to a statement from the pharmaceutical company to the stock exchanges, the Import Alert implies 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.
CGMP refers to the Current Good Manufacturing Practice regulations enforced by the USFDA. CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
The USFDA has excluded 14 products of the company from this Import Alert, subject to certain conditions.
According to the statement, for the year ended March 31, 2022, supplies to the US market from the Halol facility accounted for approximately 3 per cent of the company’s consolidated revenues, including the 14 excluded products as mentioned above.
The company said it continues to cooperate with the USFDA and would undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the company’s remedial action. It said it remains committed to being CGMP-compliant and in supplying high-quality products to its customers and patients globally. (ANI)
