The Company's Moraiya manufacturing facility has received an Establishment Inspection Report (EIR) from the USFDA. This receipt of EIR only indicates closure of the inspection points (483s) raised based on the inspection carried out between August 28 2014 and September 5 2014.
As part of the agreement, Warner Chilcott will grant Cadila and Zydus a royalty- bearing license to market a generic version of Asacol HD beginning on November 15, 2015 or earlier under certain circumstances, following receipt by Zydus of final approval from the USFDA of its ANDA for generic Asacol HD, the company said.