Great News | CATO Strategic Partner Mingjie Pharmaceutical Completes FDA Inspection
On August 8, CATO's strategic partner — Mingjie Pharmaceutical (a WuXi AppTec-controlled subsidiary) announced that within the past two weeks, Nanjing Mingjie Biopharmaceutical Testing Co., Ltd. (Nanjing Mingjie) and Shanghai Mingjie Pharmaceutical Technology Co., Ltd. (Shanghai Mingjie) had successively passed GMP inspections conducted by the U.S. Food and Drug Administration (FDA), marking that Mingjie Pharmaceutical's quality system, compliant with international standards, can now routinely accept inspections by global drug regulatory authorities.
In these inspections, the U.S. FDA dispatched different inspector teams to conduct comprehensive on-site GMP compliance inspections of the quality systems at the Nanjing Mingjie and Shanghai Mingjie laboratories. The inspections focused on project data consistency, quality system integrity, and data reliability assurance, with a comprehensive assessment and on-site inspection of Mingjie Pharmaceutical carried out across these three areas.
It is reported that Mingjie Pharmaceutical has now provided "high-quality, high-efficiency" compliant technical services covering tens of thousands of projects to nearly 3,000 pharmaceutical clients worldwide. Mingjie Pharmaceutical provides technology R&D and quality standard enhancement services in innovative drugs, improved innovative drugs, generics, biopharmaceuticals, peptides and ADC drugs, drug-device combinations, medical devices, as well as APIs, pharmaceutical excipients, and pharmaceutical packaging materials, helping clients' product quality meet global standards.
About CATO
Guangzhou CATO Research Chemicals Inc. (CATO Research Chemicals Inc.) is a national high-tech enterprise focusing on the custom synthesis of small-molecule compounds. It provides a wide range of pharmaceutical reference standards and has successively delivered custom synthesis services for challenging drug impurities and intermediates to renowned global pharmaceutical companies.
In the pharmaceutical industry, CATO provides crucial support for drug production, quality control, R&D, and clinical trials, helping to ensure drug safety, quality, and efficacy. The company's services help pharmaceutical enterprises comply with the regulations of drug regulatory authorities in various countries and reduce compliance risks. By providing pharmaceutical reference standards and other support, CATO assists pharmaceutical enterprises in better ensuring that their products meet the quality standards and regulatory requirements of the international pharmaceutical industry, thereby further improving product quality and safety.