Adhering to the concept of "Produce High Quality Pharmaceuticals to Improve Human Health", Sintaho has established and improved six GMP management systems centering on quality system strictly according to the management requirements of cGMP and ICH-Q7 for the entire product lifecycle, with clear responsibilities and strict management. GMP is implemented throughout the entire process of material procurement, pharmaceutical production, control, and product release, storage and shipment, to ensure that the drugs produced meet the intended use, RA requirements and customer requirements.
Sintaho is committed to continuous improvement and perfection of quality management system based on risk management, in order to meet the requirements of authorities and customers, and exceed customers' expectations. Sintaho pursues quality and integrity, to produce compliance, safe, effective products.
Chongqing Sintaho is a new company founded by the original team of Chongqing Taihao. It has experienced multiple quality audits conducted by domestic and foreign authorities and customers, and has accumulated rich experience in production and quality management. Chongqing Taihao used to be rated as the enterprise in Chongqing with the most varieties recognized by FDA on yaozh.com.
Quality Management System Milestones
- 2008
Passed the 1st US FDA site inspection
- 2010
Passed the 1st Japan PMDA site inspection
- 2012
Passed the 2nd US FDA site inspection
- 2014
Passed the 2nd Japan PMDA site inspection
- 2015
Passed the 3rd US FDA site inspection
- 2017
Passed the France ANSM site inspection
- 2018
Passed the 4th US FDA site inspection
- 2022
Passed the Australian TGA remote GMP inspection
Regulatory Affairs:
RA Dept. is equipped with an experienced international registration team. It has submitted DMFs to various countries including China, the United States, Europe, Canada, Japan, etc., and has accompanied multiple on-site GMP inspections conducted by relevant authorities.