Good news from a group of pharmaceutical companies that passed the FDA's on-site inspection

[pharmaceutical Station industry trends] at present, while a batch of pharmaceutical products have been approved by the FDA, there are also a batch of enterprises that have received good news of passing the FDA on-site inspection Through continuous improvement and improvement of drug production and quality management system, these pharmaceutical enterprises can ensure the quality of products and the health and safety of patients The successful FDA inspection further proves the stability and reliability of the company's quality system, or lays a solid foundation for the company's product quality and international market development, and plays a positive role in promoting the company's future development Shuangcheng Pharmaceutical Co., Ltd issued a notice on the company's passing the FDA's on-site inspection on July 1 According to the announcement, the company has accepted the FDA's comprehensive cGMP on-site inspection from April 16, 2019 to April 24, 2019, involving API intermediates, APIs and preparation products The company recently received a notice from FDA According to 21 CFR regulations of the United States, FDA confirms that the inspection has been completed and provides the company with the inspection report The notice and inspection report have made it clear that the company has passed the US FDA cGMP inspection, and the company's quality management system meets the requirements of the US FDA cGMP Shuangcheng pharmaceutical said that in recent years, the company has successfully passed the on-site inspection of FDA APIs and preparations, which will play a positive role in promoting the company's future development The company will continue to improve the pharmaceutical production and quality management system, and realize the global strategy of the company's pharmaceutical industry Fosun Pharmaceutical recently issued a notice on its holding subsidiary's production line passing the FDA's on-site inspection Chongqing Yaoyou, its holding subsidiary, received the FDA's cGMP on-site inspection from March 25, 2019 to March 29, 2019, including daily inspection and pre approval inspection (PAI) of entecavir tablets on the FDA's generic application Recently, Chongqing Yaoyou received the letter and on-site inspection report from FDA that the oral solid production line I has met cGMP standard According to the announcement, the products involved in this production line include venlafaxine hydrochloride tablets, entecavir tablets, etc the design capacity of the tablets in this production line is 1 billion tablets / year Fuxing Pharmaceutical said that Chongqing drug youentecavir tablets need to obtain (including) the approval of the US FDA generic application before being sold to the US, and the registration, production and subsequent market development of the product may be affected by many factors This inspection will not have a significant impact on the current performance of the group Yongtai Pharmaceutical Co., Ltd recently announced that its wholly-owned subsidiary Zhejiang Yongtai Pharmaceutical Co., Ltd has successfully passed the cGMP site inspection of FDA with zero defects, indicating its quality management system is FDA standard Yongtai technology said that if Yongtai pharmaceutical industry is approved anda, it will further expand the international market, facilitate the promotion of the company's preparation internationalization project, and play a positive role in improving the company's comprehensive competitiveness and promoting the company's future development On May 7, the new third board company, Kangle pharmaceutical, issued a notice saying that from March 18 to 22, 2019, the US FDA conducted on-site FDA inspection on the company The company recently received the eir report from FDA, confirming that it passed the FDA's on-site inspection Kangle pharmaceutical said that the company successfully passed the FDA on-site inspection, which is conducive to expanding the European and American markets, improving the competitiveness of the international market, and has a positive impact on the company's future business performance Fuxiang Pharmaceutical Co., Ltd issued a notice on the company's passing the U.S FDA certification on June 12 From January 14, 2019 to January 18, 2019, the company received cGMP on-site inspection from the U.S FDA This inspection mainly focuses on the production and manufacturing management of intravenous antibacterial intermediates and APIs (tazobactam, sulbactam, piperacillin) The inspection scope covers quality system, material management system, production management system, equipment and facilities system, packaging and labeling system, laboratory control system and other GMP systems According to the inspection report, the company's tazobactam, sulbactam and piperacillin products have passed the FDA's on-site quality inspection with zero defects According to the inspection report, the company meets the requirements of cGMP specification of American drugs and has passed the FDA certification The company said that the successful passing of the FDA on-site inspection is a high affirmation of the effective operation of the company's management system, which will promote the realization of the company's development goals and expand the global market and bring a positive impact on the company's production and operation.