The US Food and Drug Administration (FDA) has listed Sun Pharmaceuticals’ facility in Gujarat’s Halol under an import alert, said the Indian drugmaker on Thursday, sending its shares down 2.37 per cent in morning trade at the BSE.
Analysts expected there will be a 2-3 percent hit on Sun’s top-line and a 5-6 percent impact on EBITDA as a result of the FDA action. “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,” said the company in an exchange notification.
The USFDA has excluded 14 products from the import alert subject to certain conditions, said Sun, the eighth largest pharmaceutical company in the US generics market.
“For the year ended March 31, 2022, supplies to the US market from the Halol facility accounted for approximately 3 percent of the company’s consolidated revenues, including the 14 excluded products as mentioned above,” it said.
FDA inspected the facility from April 26 to May 9, 2022 and then issued a form with 10 observations. The facility was classified ‘Official Action Indicated (OAI)’ in March 2020, and was awaiting re-inspection from the US regulator. Due to travel restrictions for the pandemic, the re-inspection got delayed, and in May the FDA issued a form 483 with observations, which is an improvement over the OAI status.
The company expected a FDA re-inspection of the facility. “My understanding broadly, is that if you get an OAI, then depending on the FDA’s expectation, we will continue to address all the observations and remediation efforts. But most of the time, they will revisit the facility before it becomes a VAI (voluntary action indicated),” said Dilip Shanghvi, managing director of Sun Pharma, during the second quarter earnings call earlier.
Sun Pharma said on Thursday that it is cooperating with the FDA and will undertake steps to resolve these issues and to ensure that the regulator is completely satisfied with remedial action.
The Halol facility of Sun Pharma has been under the USFDA radar for the last few years. In December 2019, the USFDA inspected the Company’s Halol facility and issued Form 483 with 8 observations. Following submission of the company’s response in January 2020, the USFDA classified the inspection status as Official Action Indicated (OAI).