Sun Pharma temporary pause in release of batches from Mohali until US FDA mandated measures are implemented

Sun Pharma has received a letter titled “CONSENT DECREE CORRESPONDENCE/NON-COMPLIANCE LETTER” from the US FDA. US FDA has directed the Company to take certain corrective actions at the Mohali facility before releasing further final product batches into the US. These actions include, among others, retaining an independent CGMP expert to conduct batch certifications of drugs manufactured at the Mohali facility. The Company is taking required corrective steps, but there will be a temporary pause in release of batches from Mohali until US FDA mandated measures are implemented. US shipments from Mohali will resume once these measures are in place.