Sinotherapeutics INC. (hereafter SinoT) has received the current routine cGMP inspection by the U.S. FDA from March 13 to15, 2024. This current routine cGMP inspection covered the following systems: Quality System, Facilities & Equipment System, and the Laboratory Control System.
In June of 2024, SinoT has received the acceptance letter from FDA, which confirmed that SinoT passed this cGMP inspection with no action indicated, NAI.
This inspection is not only a recognition of the effective operation of SinoT's quality system, but also a result of SinoT's strict implementation of international GMP standards throughout the whole lifecycle. Previously, SinoT has passed cGMP inspections by the U.S. FDA multiple times.
About SinoT：
SinoT is a specialty pharma with focus on the research & development, commercialization and sale of complex generics and 505(b2) products. We dedicated to developing high quality medicines that meet with international standards. We’ll do more than our best to benefit the patients in the future.
Shanghai Head Office
99 Haike Road, Bldg. 3, 1st Flr., Pudong District Shanghai 201210, P.R. China
Manufacturing Site in Jiangsu
No. 163 Zhuhai Road, Haimen Area, Nantong City, Jiangsu Province
