carelife pharma passed fda's site inspection with "zero defect" for the third time successively
recently, yao pharma co., ltd. (hereinafter referred to as “yaopharma”), a member of fosun pharma, brought a good news: an api (active pharmaceutical ingredient) manufacturer under yaopharma – chongqing carelife pharmaceutical co., ltd (hereinafter referred to as “carelife pharma”) passed fda's site inspection with zero defect for the third time successively. this is another answer sheet delivered by carelife pharma after it smoothly entered the "top 100 internationalized pharmaceutical enterprises in china" in june 2017.
in recent years, fda intensified the inspection on chinese pharmaceutical companies and it has become more and more difficult for chinese pharmaceutical companies to pass the certification. for this certification, fda systematically inspected the production system of carelife pharma, involving wider inspection scope and more aspects.
during the inspection, the inspector comprehensively and thoroughly inspected six cgmp-related systems of carelife pharma, including quality management system, quality control system, facilities and equipment system, materials management system, production management system and packaging and labeling system, and carefully inspected the process, equipment, environment and quality system of the production site. the inspector highly regarded the site environment of carelife pharma and rated the effective operation of the quality system high, and announced on the site that carelife pharma smoothly passed the fda's site inspection with zero defect.
according to wang fan, vice chairman of yaopharma and executive director of carelife pharma, this certification resulted from strict implementation of cgmp standard of carelife pharma, which laid a solid foundation for carelife pharma to further develop international market and enhance its competitiveness on international market.
yaopharma, a member enterprise of fosun pharma, is a group-oriented and national key hi-tech enterprise of a complete pharmaceutical industry chain integrating api and formulation development, production and sales, which has been rated as one of the "top 100 enterprises of comprehensive strength in china's chemical industry" for 10 consecutive years.
yaopharma is committed to break down market barriers between china and abroad and focusing on "those new, advanced and hard" in product development. its api have passed cgmp certifications of the united states’ fda, european union’s edqm, pmda of japan's ministry of health and welfare, etc. in terms of formulation, it has introduced advanced production lines and production technologies from germany, italy, japan and united states and has become china's first pharmaceutical enterprise whose prescribed formulations passed canada's cgmp; its solid formulation production lines have passed the us cgmp, one of a few enterprises nationwide and the only enterprise in west china. in 2015, the formulation made by the company –quetiapine fumarate extended-release tablets were exported to canada's market for the first time and the first independently developed anda formulation of the company – venlafaxine tablets were launched in the us market in 2016.
carelife pharma is an api manufacturer of yaopharma, and is committed to developing the international code markets in the long run. besides, it has established widespread partnerships with many well-known multinational pharmaceutical enterprises. over 75% of its products are sold to europe, us and other code markets, wherein, it has become the largest clindamycin hydrochloride series product’s supplier in the us market.