"Zero defect" of Kailin pharmaceutical has passed on-site inspection by FDA

[chinapharma.com Enterprise News] Kailin pharmaceutical is a pharmaceutical raw material manufacturer under Yaoyou pharmaceutical It has been committed to the development of international regulatory market for a long time, and has established extensive cooperation with many multinational pharmaceutical enterprises Yuyou pharmaceutical is committed to breaking through the barriers of domestic and international pharmaceutical market, and its product development focuses on "new, first and difficult" Recently, Kailin pharmaceutical passed the FDA on-site inspection for the third time in a row with zero defects (picture source: Baidu picture) recently, Kailin pharmaceutical, a raw material drug manufacturing enterprise of pharma Youyao, a member enterprise of Fosun Pharmaceutical, passed the FDA's on-site inspection for the third time in a row with zero defects This is another answer sheet after Kailin pharmaceutical successfully entered the "top 100 international pharmaceutical enterprises of China" in June 2017 In recent years, the U.S FDA has increased the inspection of Chinese drug manufacturers, and it is more and more difficult to pass the certification This certification is a systematic inspection of Kailin pharmaceutical production system by FDA, with a wider inspection scope and more involved levels During the inspection, the inspector comprehensively and thoroughly reviewed the six cGMP systems involved in Kailin pharmaceutical quality management system, quality control system, facilities and equipment system, material management system, production management system, packaging and labeling system, and carefully inspected the production site process, equipment, environment, quality system, etc The inspector gave a good affirmation to Kailin pharmaceutical's site environment, gave a high evaluation to the effective operation of the quality system, and announced on the site that Kailin pharmaceutical passed the FDA's site inspection successfully Wang Fan, vice chairman of Yaoyou pharmaceutical and executive director of Kailin pharmaceutical, said that the successful certification was the result of Kailin pharmaceutical's strict implementation of cGMP standards, and laid a solid foundation for Kailin pharmaceutical to continue to expand the international market and improve its competitiveness in the international market Business card: Yaoyou pharmaceutical, a member enterprise of Fosun Pharmaceutical, is a group and key high-tech enterprise integrating the R & D, production and sales of API and preparations, with a complete pharmaceutical industry chain It has been awarded the "top 100 comprehensive strength enterprises of China's chemical industry" for 10 consecutive years Yuyou pharmaceutical is committed to breaking through the barriers of domestic and foreign pharmaceutical market, and its product development focuses on "new, first and difficult" The API has passed cGMP certification such as FDA of the United States, EDQM of the European Union and PMDA of the Ministry of health and welfare of Japan In the field of preparations, we have introduced advanced preparation production lines and production technologies from Germany, Italy, Japan and the United States, and become a pharmaceutical enterprise with Canadian cGMP certification for prescription preparations in China; solid preparation production line has become one of the few enterprises in China, and a western enterprise with cGMP certification in the United States In 2015, quetiapine fumarate sustained release tablets, a preparation product produced by the company, were exported to the Canadian market In 2016, the Anda preparation product independently developed by the company, venlafaxine tablets, was listed in the United States Kailin Pharmaceutical Co., Ltd is a pharmaceutical raw material manufacturer under Yaoyou pharmaceutical It has been committed to the development of international regulatory market for a long time, and has established extensive cooperation with many multinational pharmaceutical enterprises More than 75% of its products are sold to European and American regulatory markets, among which clindamycin hydrochloride series products have become a major supplier in the U.S market.