Ningbo Menovo Pharmaceutical (603538.SH): Xuancheng Ningbo Menovo Pharmaceutical's Tildipirosin API passes FDA on-site inspection for the first time

date
16:09 05/11/2026
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GMT Eight
Ningbo Menovo Pharmaceutical (603538.SH) announced that its controlled subsidiary Xuancheng Ningbo Menovo Pharmaceutical Co., Ltd. ("Xuancheng Menovo") underwent a U.S. Food and Drug Administration ("FDA") cGMP (current Good Manufacturing Practice) on-site inspection from June 22 to June 26, 2026. The inspection covered various GMP systems including the quality system, materials management system, production management system, equipment and facilities system, packaging and labeling system, and laboratory control system. The product inspected: tildipirosin.
Ningbo Menovo Pharmaceutical (603538.SH) announced that its controlled subsidiary Xuancheng Ningbo Menovo Pharmaceutical Co., Ltd. (hereinafter "Xuancheng Ningbo Menovo Pharmaceutical") underwent a cGMP (Current Good Manufacturing Practice) on-site inspection by the U.S. Food and Drug Administration (hereinafter "FDA") from June 22 to June 26, 2026. The inspection covered various GMP systems including the quality system, materials management system, production management system, equipment and facilities system, packaging and labeling system, and laboratory control system. The product inspected: tildipirosin. On November 4, 2026, Xuancheng Ningbo Menovo Pharmaceutical received the Establishment Inspection Report (EIR) issued by the FDA, which indicates that Xuancheng Ningbo Menovo Pharmaceutical (No. 9 Meizigang Road, Xuancheng High-tech Industrial Development Zone, Anhui) has passed this cGMP on-site inspection.