Apeloa Pharmaceutical recently announced that Zhejiang Apeloa Jiayuan Pharmaceutical Co., Ltd., one of its subsidiaries, has received approval from China's National Medical Products Administration (NMPA) for the Marketing Authorization Application (MAA) of its domestically manufactured deutenzalutamide active pharmaceutical ingredient (API).
The approval marks the successful completion of regulatory registration for this innovative-drug CDMO API project undertaken by Apeloa. It enables the company to supply compliant, reliable API volumes to its partner, ensuring stable commercial production of deutenzalutamide soft capsules.
As the CDMO partner of Hinova Pharmaceuticals, Apeloa is responsible for supplying the API for this drug product, underpinning its commercialization with stable, compliant supply. The two companies have maintained a deep, stable strategic partnership over the years. Driven by Apeloa's stringent quality control, mature manufacturing processes, and reliable delivery capabilities, the company has been named Hinova's "Annual Excellent Supplier" for three consecutive years — reflecting Hinova's strong recognition of Apeloa's comprehensive CDMO capabilities.
The approval of the deutenzalutamide API demonstrates Apeloa's integrated strengths in CDMO R&D, commercial-scale manufacturing, and quality system assurance. It will also further enrich the company's portfolio of innovative-drug APIs and secure the regulatory foundation for sustained, stable supply of this medicine.
Going forward, Apeloa will continue to deepen its commitment to the CDMO space, focusing on the core needs of innovative drug commercialization. By delivering high-quality, customized R&D and manufacturing services, the company will help its partners bring innovative medicines to market — making quality therapies accessible to more patients.
