Sun Pharma's Mohali plant in Punjab receives OAI status from USFDA

Sun Pharmaceutical Industries said that their Mohali plant in Punjab received an official action indicated (OAI) classification from the US Food and Drug Administration (USFDA). This can impact approvals pending for products, but does not impact the current business from the facility. 

The plant was inspected in August and had received a form 483 with six observations earlier. The typical process is that the firm concerned responds to the queries raised by the FDA  and a resolution is based on whether the FDA is satisfied by the corrective actions taken by the company. Sun Pharma has now received communication from the FDA determining the classification of the inspection. 

The company said on Tuesday, " We now wish to inform you that the Company has received a communication from the USFDA determining the inspection classification as “Official Action Indicated” (OAI)." It added that the communication further states that  the USFDA may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved and may initiate additional actions. 

"The Company continues to manufacture and distribute existing products for the US market, thereby not likely to have any material adverse impact on current business from the facility," Sun Pharma claimed. 

"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," it added.