Shares in Sun Pharma fell by 2 per cent, after the US FDA indicated that the Halol facility of the company has been classified as "Official Action Indicated" (OAI).
"This is with respect to our communication dated December 13, 2019 regarding the USFDA inspection at the Company's Halol (Gujarat) facility from December 03-13, 2019 and issuance of Form 483 by USFDA with eight observations. We now wish to inform you that the Company has received a communication from the USFDA indicating that the Halol facility has been classified as "Official Action Indicated" (OAI)," Sun Pharma said in a notice to the exchanges.
The OAI classification implies interalia that the USFDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved.
"The Company continues to manufacture and distribute existing products for the US market, thereby not likely to have any adverse impact on current business from the facility. Sun Pharma 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.