ChemExpress Completes First U.S. FDA Inspection at Anhui Haoyuan Pharmaceutical Co., Ltd. (Taodian Avenue Division) with No Form FDA 483 Observations
ChemExpress Completes First U.S. FDA Inspection at Anhui Haoyuan Pharmaceutical Co., Ltd. (Taodian Avenue Division) with No Form FDA 483 Observations
A Significant Milestone in Global Quality Compliance, Strengthening API and HPAPI CDMO Services for Global Pharmaceutical Innovation
ChemExpress (Shanghai Haoyuan Chemexpress Co., Ltd.) recently announced that its wholly owned subsidiary, Anhui Haoyuan Pharmaceutical Co., Ltd. (Anhui Haoyuan), has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) following the first FDA inspection of its Taodian Avenue Division (commonly referred to as ChemExpress' Ma'anshan site).
Conducted in August 2026, the inspection covered six key cGMP systems associated with active pharmaceutical ingredient (API) manufacturing. No Form FDA 483 inspectional observations were issued, marking an important milestone in the site's ongoing commitment to international quality standards, cGMP compliance, and operational excellence.
First FDA Inspection: Comprehensive Assessment of Six cGMP Systems
According to the FDA inspection report, the 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.
Using a systems-based approach, FDA investigators evaluated six key cGMP systems:
- Quality System
- Facilities and Equipment System
- Materials System
- Production System
- Packaging and Labeling System
- Laboratory Control System
The inspection also assessed the site's manufacturing operations for APIs and pharmaceutical intermediates intended for use in human drug products supplied to the U.S. market.
As the site's first U.S. FDA inspection, the outcome of no Form FDA 483 observations represents a significant achievement, reflecting Anhui Haoyuan's continued investment in quality management, manufacturing controls, and cGMP-compliant operations.
Strengthening Global Quality Standards to Serve Regulated Markets
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.
The successful completion of this FDA inspection reflects the continued advancement of quality management practices at the Ma'anshan site and demonstrates its capabilities in API and highly potent API (HPAPI) manufacturing, quality assurance, and regulatory compliance.
This milestone further strengthens ChemExpress' foundation for supporting international customers and expanding its CDMO services across global regulated markets.
Advancing API and HPAPI CDMO Capabilities from Development to Commercial Manufacturing
As an important component of ChemExpress' integrated CDMO network, the Ma'anshan site focuses on API and HPAPI CDMO services, with capabilities spanning process scale-up, cGMP manufacturing, and commercial supply.
Leveraging ChemExpress' 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.
The positive outcome of this FDA inspection further reinforces the quality foundation supporting future API, HPAPI, and related CDMO projects for customers targeting global regulated markets.
Leadership Perspective: Quality and Compliance at the Core of Customer Success
Dr. Yonggang Chen, SVP and CTO of ChemExpress, commented:
"Successfully completing our first U.S. FDA inspection with no Form FDA 483 observations is an important milestone in Anhui Haoyuan's ongoing development of an internationally aligned quality management system. It also reinforces our responsibility to maintain the highest standards of quality, compliance, and reliable project delivery.
Building on our technical expertise and manufacturing capabilities in APIs and HPAPIs, we have established an integrated service platform covering technology transfer, process scale-up, cGMP manufacturing, and commercial supply.
Looking ahead, we will continue to strengthen our quality systems and operational capabilities in accordance with international cGMP standards, providing global customers with reliable, compliant, and high-quality CDMO services."
Expanding Global CDMO Capabilities Through Quality, Innovation, and Operational Excellence
The successful completion of the first U.S. FDA inspection at the Ma'anshan site represents another important step in ChemExpress' ongoing efforts to strengthen its global quality and compliance capabilities.
Looking ahead, ChemExpress will continue to place customer needs at the center of its operations, with technological innovation and quality compliance serving as the foundations of its growth.
By further integrating its R&D expertise, cGMP manufacturing capabilities, and global service network, ChemExpress aims to deliver high-quality, efficient, and reliable end-to-end CRO and CDMO solutions, supporting pharmaceutical and biotechnology partners from drug discovery and development through clinical manufacturing and commercialization.
ChemExpress — Empowering Global Pharmaceutical Innovation Through Advanced Technologies and International Quality Standards.