Sun Pharma gets OAI for Halol facility from USFDA

30 Mar 2020 Evaluate

Sun Pharmaceutical Industries has received a communication from the United States Food and Drug Administration (USFDA) indicating that the Halol facility has been classified as Official Action Indicated (OAI). The OAI classification implies 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.

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. The company remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally.

Sun Pharmaceutical Industries is the world’s fourth largest specialty generic pharmaceutical company and India’s top pharmaceutical company.

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