Hybio Pharmaceutical Liraglutide injection was tentatively approved by the US FDA
2021.09——ANDA Initial submission
2021.10——ANDA successfully accepted
2021.11——Liraglutide raw material was registered by DMF
2023.10——Hybio Pharmaceuticals’ subsidiary, (the base of preparation production) Pingshan Branch, completed an on- site inspection by the United States Food and Drug Administration (FDA) for current Good Manufacturing Practices(cGMP)
2023.11——Hybio Pharmaceuticals'subsidiary, (the base of Raw material pharmaceutical) WuHan Branch, completed an on-site inspection by the United States Food and Drug Administration (FDA) for current Good Manufacturing Practices (cGMP)
2023.12——Hybio Pharmaceuticals’ parent company, (the center of Research and development ) completed an on-site inspection by the United States Food and Drug Administration (FDA) for current Good Manufacturing Practices (cGMP)
2024.02——NFC feedback results were obtained for liraglutide
2024.03—— Complete the last round of CRL reply
2024.06——The first batch of Liraglutide injection was transported to the United States and lastly received tentative approval from the US FDA