Sun Pharma Receives U.S. FDA Warning Letter For Halol Facility

(RTTNews) - Sun Pharmaceutical Industries Ltd said that it has received a Warning Letter from the U.S FDA as a result of the September 2014 inspection, for its facility located at Halol, Gujarat in India.

Sun Pharma noted that it responded to the US FDA inspection observations with a robust remediation process that is still on-going, with significant investments in automation and training to enhance its Quality Systems. Sun Pharma has been working with external consultants to ensure its remediation activities have been completed in an appropriate manner.

Commenting on the development, Dilip Shanghvi, Managing Director, Sun Pharma said, "While our team is working hard to ensure that the commitments made to the US FDA in September 2014 are fully completed, we will continue to cooperate with the US FDA and undertake any additional steps necessary to ensure that the US Agency is completely satisfied with our remediation of the Halol facility."

Since the inspection in September 2014, Sun Pharma has communicated regularly with the US FDA on the progress of its remediation and on issues of product supply. It has provided periodic updates to the US FDA on its commitments. Post the September 2014 inspection, the US FDA has withheld future product approvals from the Halol facility. This situation may continue until all issues are resolved.

Sun Pharma expects to request a re-inspection by US FDA upon completion of its remediation commitments.

Sun Pharma and the Halol facility will continue to supply important drug products to meet its obligations to its customers and the patients who use its drugs in the United States and around the world.

Sun Pharma noted that it will respond to this Warning Letter with a detailed plan within the stipulated time frame.