Apeloa Successfully Passes 20th FDA Inspection With No Action Indicated

Following a rigorous and comprehensive evaluation process, Apeloa Pharmaceutical has successfully passed its 20th US FDA inspection, a top achievement in the industry that underscores Apeloa’s exemplary quality and management standards.

Hengdian, China - Apeloa Pharmaceutical, a global leader in technology-driven pharmaceutical manufacturing solutions, announced that it successfully passed its 20th U.S. Food and Drug Administration (FDA) inspection, a remarkable milestone in the company’s history.

Zhejiang Apeloa Tospo Pharmaceutical Co., Ltd., a subsidiary of Apeloa that provides manufacturing services for Raw Starting Materials (RSMs), Intermediates, and Active Pharmaceutical Ingredients (APIs) for both clinical and commercial use, passed the FDA inspection with No Action Indicated (NAI) on 24 October 2025.

The routine current Good Manufacturing Practice (cGMP) surveillance inspection evaluated Apeloa’s US-bound exports and products registered in the U.S. FDA oTicers assessed the site based on six factors: quality system, production system, materials system, equipment and facilities system, packaging and labeling system, and laboratory control system.

This NAI result indicates that there were no objectionable items found during the inspection and that no Form 483s (used to inform companies of objectionable conditions) were issued, following a five-day inspection involving a wide range of in-depth and systematic checks.

The FDA also recognized Apeloa’s exemplary performance in compliance management, process control and data integrity. This result endorses Apeloa’s end-to-end quality control capabilities.

About Apeloa

Founded in 1989, Apeloa is the pharmaceutical subsidiary of Hengdian Group and one of China’s top 2 API exporters and top 5 CDMO companies. Throughout its development, Apeloa has consistently observed strict adherence to top global standards in quality management.

Since 2006, Apeloa has successfully passed 20 FDA inspections, including four consecutive FDA onsite inspections in just the past two years resulting in NAI. Its various manufacturing sites are also certified by major global regulators including EDQM, NMPA, PMDA, KFDA.

This global recognition reflects Apeloa’s high level of consistency and reliability, reduces regulatory risks, and expands Apeloa’s presence in global markets. This strengthens Apeloa’s position as a trusted partner to global pharmaceutical companies in Europe and the United States.

Globally, Apeloa’s core businesses include API, CDMO, FDF and Aesthetics and Care Ingredients (ACI). Its services are supported by advanced technical platforms with over 1300 scientists in R&D centers in Boston, Shanghai and Hengdian, and global branches in Germany, the US and Japan.