HENGDIAN, China, October 15, 2026 — Apeloa Pharmaceutical announced that its subsidiary, Shandong Apeloa Tospo Pharmaceutical Co., Ltd., has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA), confirming that the YP265 gas active pharmaceutical ingredient (API) CDMO project has successfully passed the agency's Pre-Approval Inspection (PAI). YP265 is the first gas API project in China to receive this certification.
During the inspection, the FDA team evaluated the project's GMP systems across six areas — Quality, Facilities and Equipment, Materials, Production, Packaging and Labeling, and Laboratory Controls — through facility walkthroughs, document reviews, process verification, and personnel interviews. Passing the inspection demonstrates that the project's manufacturing and quality management systems meet international regulatory standards.
Gas APIs face far more demanding requirements than conventional APIs: production containment, process stability, material storage and transport, contamination control across the entire process, and batch-to-batch consistency. Industrial-scale production and compliant quality system establishment remain common challenges across the industry.
To meet these challenges, the YP265 project adopts continuous manufacturing with computerized end-to-end process control, enabling uninterrupted operation from material feeding and reaction through process adjustment and finished product collection. Critical process parameters are monitored and recorded in real time, with automatic alerts for any deviation. The model minimizes manual intervention while improving process stability, data traceability, and production efficiency — offering a viable route to large-scale, standardized production of gas APIs.
As a CDMO project, YP265 further expands Apeloa's technology base and commercialization capabilities in specialty APIs, enabling the company to supply stable API volumes and commercial production support to global customers developing innovative drugs — and strengthening its differentiated position in high-end, complex APIs and novel specialty formats.
Several Apeloa manufacturing sites have previously passed inspections by the FDA, the European Medicines Agency (EMA), and other international regulators. This latest clearance further cements the company's internationally compliant manufacturing capabilities and strengthens its foundation for taking on global CDMO projects.
