Agora Highlights WuXi AppTec's FDA Success in API Manufacturing Facilities

### WuXi AppTec Achieves Major Milestones in API Manufacturing

WuXi AppTec, a prominent player in the pharmaceutical and life sciences sectors, marks a significant achievement with its Active Pharmaceutical Ingredient (API) manufacturing sites in Changzhou and Taixing, China. Recently, both facilities successfully pass inspections conducted by the U.S. Food and Drug Administration (FDA), demonstrating the company's unwavering commitment to high-quality manufacturing standards. The Changzhou site, which underwent a Good Manufacturing Practice (GMP) surveillance inspection starting March 4, impressively concludes the evaluation a day early, with no observations noted by the FDA. This inspection not only underscores the facility's compliance with rigorous regulatory standards but also reinforces WuXi AppTec’s reputation as a reliable partner in drug development.

Following the successful inspection in Changzhou, the Taixing site completes a Pre-Approval Inspection (PAI) on March 21 for a peptide-based therapeutic. This facility, operational since September 2023 and spanning an impressive 169 acres, stands as WuXi AppTec's largest API manufacturing site, primed to support commercial API supply on a global scale. Dr. Minzhang Chen, Co-CEO of WuXi AppTec, underscores the importance of quality and compliance in enabling global partners to advance drug development and commercialization. The successful inspections not only validate the infrastructure and technical expertise at these sites but also position WuXi AppTec as a leader in the API manufacturing landscape.

The Changzhou and Taixing facilities are integral components of WuXi STA, the company's small molecule Contract Development and Manufacturing Organization (CDMO) platform, as well as WuXi TIDES, which focuses on peptide-based therapeutics. This achievement reflects WuXi AppTec's ongoing dedication to supporting healthcare innovators and facilitating the delivery of essential therapies to patients worldwide. By ensuring that their manufacturing sites meet the highest standards, WuXi AppTec not only bolsters its operational capabilities but also enhances the potential for collaboration with global pharmaceutical companies.

In addition to these impressive inspection results, WuXi AppTec's commitment to high-quality R&D services remains a cornerstone of its operational strategy. The company continues to expand its footprint in the pharmaceutical manufacturing space, enabling it to cater to the increasing demand for innovative therapies. With the successful validation of its Changzhou and Taixing sites, WuXi AppTec is well-positioned to play a pivotal role in the global healthcare landscape.

Moreover, the advancements in WuXi AppTec's manufacturing capabilities align with the growing trend towards greater demand for reliable API sources, as pharmaceutical companies seek partners that can ensure compliance and quality at every stage of the drug development process. This development not only highlights WuXi AppTec's strengths but also underscores its potential to lead in an increasingly competitive market.