Sun Pharma's Halol Facility In USFDA's 'Import Alert List', US Entry Restricted For Products

Pharmaceutical major, Sun Pharma on Thursday gave an update on the inspection by USFDA at its Halol facility in Gujarat, the pharma major said that its facility has been listed under the Import Alert list by the USFDA. 

The Import Alert implies interalia, 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.

"We now wish to inform you that the Company has received a communication from the USFDA stating that the facility has been listed under Import Alert," the company said in a regulatory filing.

The company also said that the US regulator has excluded 14 products from the Import Alert list subject to some conditions. The company's exports from the halol facility contribute to around 3 per cent of its consolidated revenue. 

"The USFDA has excluded 14 products from this Import Alert subject to certain conditions. For the year ended 31-March-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," the company's statement read.

Sun Pharma stated that it will continue to cooperate with the top US regulator and will undertake corrective measures to solve the issues.

"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. Sun Pharma remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally," the company said.