Menovo subsidiary passes first US FDA on-site inspection for tildipirosin API
November 6, 2026
Source: drugdu
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Menovo (603538) disclosed on November 6 that its controlled subsidiary, Xuancheng Menovo, received a US FDA inspection report on November 4 confirming that it had passed its first FDA on-site inspection for tildipirosin API. The preapproval cGMP inspection ran from June 22 to 26, 2026, and covered quality, materials, manufacturing, facilities and equipment, packaging and labeling, and laboratory controls.
The company said the inspection outcome would support its international expansion. Menovo develops, manufactures and sells specialty APIs and finished dosage forms. In the first nine months of 2026, revenue rose 29.00% year on year to RMB 1.441 billion, and net profit attributable to shareholders rose 8.54% to RMB 104 million.
Source: http://finance.eastmoney.com/a/202611063924413520.html
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