No Form FDA 483 Observations in ChemExpress Ma'anshan Site Inspection

SHANGHAI, SHANGHAI, CHINA, November 2, 2026 /CourierPR/ -- ChemExpress, a global contract development and manufacturing organization (CDMO) specializing in active pharmaceutical ingredients (APIs) and highly potent APIs (HPAPIs), has achieved a significant milestone with the successful completion of its first U.S. Food and Drug Administration (FDA) inspection at its Ma'anshan site. The inspection, conducted in August 2026, covered six key current good manufacturing practice (cGMP) systems, and no Form FDA 483 observations were issued.

The inspection evaluated the Ma'anshan site's quality system, facilities and equipment, materials, production, packaging and labeling, and laboratory control systems. These systems are critical for ensuring the safety, quality, and efficacy of APIs and pharmaceutical intermediates intended for use in human drug products supplied to the U.S. market. The absence of Form FDA 483 observations signifies that the site has met the stringent regulatory requirements set by the FDA.

Dr. Yonggang Chen, Senior Vice President and Chief Technology Officer (CTO) of ChemExpress, commented on the significance of this achievement.

This milestone underscores ChemExpress's dedication to quality and compliance in its API and HPAPI manufacturing processes. The company's Ma'anshan site, which focuses on API and HPAPI CDMO services, has established an integrated service platform covering technology transfer, process scale-up, cGMP manufacturing, and commercial supply. By leveraging its expertise in pharmaceutical research and development, ChemExpress aims to provide global customers with reliable, compliant, and high-quality CDMO solutions.

The positive outcome of this FDA inspection further strengthens ChemExpress's foundation for supporting international customers and expanding its CDMO services across global regulated markets. As an integral part of ChemExpress's integrated CDMO network, the Ma'anshan site is well-positioned to meet the growing demand for advanced pharmaceutical manufacturing capabilities. The site's first U.S. FDA inspection was conducted under the FDA's Fiscal Year 2026 work plan and Compliance Program CPGM 7356.002F, Active Pharmaceutical Ingredient (API) Process Inspection, using a systems-based approach.

The inspection assessed the site's manufacturing operations for APIs and pharmaceutical intermediates intended for use in human drug products supplied to the U.S. market. The evaluation of the six key cGMP systems, Quality System, Facilities and Equipment System, Materials System, Production System, Packaging and Labeling System, and Laboratory Control System, ensured that the Ma'anshan site adheres to the highest standards of quality and compliance. This outcome reflects ChemExpress's continued investment in quality management, manufacturing controls, and cGMP-compliant operations.

The successful completion of this FDA inspection marks an important milestone in the site's ongoing commitment to international quality standards, cGMP compliance, and operational excellence. Quality and regulatory compliance are fundamental to pharmaceutical development and manufacturing, particularly for CDMO partners supporting innovative therapies across global markets. ChemExpress remains committed to continuously strengthening its quality management systems in alignment with international cGMP requirements. Quality and compliance are integrated throughout critical stages of pharmaceutical development and manufacturing, including process development, technology transfer, scale-up, quality control, cGMP manufacturing, and commercial production.

This milestone further strengthens ChemExpress's foundation for supporting international customers and expanding its CDMO services across global regulated markets. The Ma'anshan site's focus on API and HPAPI CDMO services, with capabilities spanning process scale-up, cGMP manufacturing, and commercial supply, positions it to meet the growing demand for advanced pharmaceutical manufacturing capabilities. Leveraging ChemExpress's expertise in pharmaceutical R&D, process chemistry, and manufacturing scale-up, the site works closely with the company's broader R&D and manufacturing network to support customers throughout the drug development lifecycle. From early-stage development and technology transfer to clinical and commercial manufacturing, ChemExpress is committed to providing integrated, reliable, and scalable CDMO solutions that help pharmaceutical and biotechnology companies advance innovative therapies efficiently.