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Apeloa Pharmaceutical Passes 20th FDA Inspection

Zhejiang Apeloa Tospo Pharmaceutical Co. Ltd., a subsidiary of Apeloa, passed the FDA inspection with No Action Indicated on October 24, 2025.

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By: Charlie Sternberg

Associate Editor, Contract Pharma

Apeloa Pharmaceutical, a global provider of technology-driven pharmaceutical manufacturing solutions, has successfully passed its 20th U.S. Food and Drug Administration (FDA) inspection, a 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 October 24, 2025.

The routine current Good Manufacturing Practice (cGMP) surveillance inspection evaluated Apeloa’s U.S.-bound exports and products registered in the U.S. The site was assessed 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.

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