As late summer transitions to early autumn in 2025, with the lingering summer heat gently receding and the delicate aroma of osmanthus starting to permeate the air, Sichuan Xieli Pharmaceutical Co., Ltd. proudly received official confirmation of its compliance with Pharmaceutical Manufacturing Quality Management Practices from Japan PMDA (Pharmaceutical and Medical Device Agency). This milestone comes as Xieli Pharma successfully navigated post-pandemic challenges since 2023 to re-secure the prestigious PMDA certification, further enhancing its robust international certification framework. Building on prior accreditations from the U.S.FDA and EU EDQM, this latest achievement marks another pivotal step forward in the company’s global expansion journey. 

I. Certification Value: Compliance Verification for the Japanese Market

In the global pharmaceutical regulatory system, Japan's PMDA certification is characterized by strict whole-life-cycle supervision, covering multiple links such as API stability, production environment control, R&D data traceability, and clinical risk early warning. Its numerous assessment indicators place high demands on enterprises' comprehensive management capabilities.

To secure this certification, Xieli refined its end-to-end quality management system in strict alignment with PMDA standards, enabling full-process data traceability from raw material selection to finished product release. The company also established a dedicated international certification task force, which gained in-depth familiarity with certification criteria through repeated simulated audits. Additionally, it built multi-tiered quality control barriers to ensure production deviations are effectively controlled and all data remains fully traceable.

When the PMDA inspection team concluded that Xieli met the requirements, it was not only a recognition of its products but also a reflection of Xieli's development philosophy of adhering to quality oriented development. Against the backdrop of global pharmaceutical industry restructuring, the PMDA certification provides a reference for enterprises to participate in international market competition. Through this certification, XX Pharmaceutical has demonstrated the ability of Chinese pharmaceutical companies to align with international markets in quality management.

II. Foundation of Internationalization: Synergistic Effect of Certification Matrix

Since its founding in 1980, the company has stayed true to its founding mission of "Collaborating to Create Health Career" and has dedicated unwavering efforts to domains including ecological medicinal herb cultivation and natural active ingredient extraction. Over time, it has developed a robust product portfolio with drug registrations spanning dozens of countries. Among these, products such as rutinoids and plant flavonoids have gained global recognition, reaching nearly 50 countries worldwide thanks to their consistently reliable quality.

What is worth to mention, prior to this PMDA certification, Xieli had already obtained multiple international authoritative certifications, including those from the U.S. FDA, EU EDQM, and Japan PMDA, establishing quality systems connected to multiple mainstream markets. The significant value of PMDA certification lies in driving enterprises to continuously improve on the basis of meeting existing standards. As the PMDA certification synergizes with existing international qualifications, Xieli has gradually grown from a simple product exporter to a trustworthy partner in the global pharmaceutical supply chain.

III. From Regional Expansion to Global Layout: Extended Value of PMDA Certification

In the short term, this certification will help Xieli's products enter the Japanese domestic market more smoothly. Meanwhile, it will provide support for further exploring the European market, which is expected to bring positive impacts on the development of international business.

And in the long run, the management experience and technical standards accumulated during the PMDA certification process are providing tangible impetus for Xieli's development.

The certification journey of Xieli reflects the evolution of China's pharmaceutical industry from catching up to collaborative development. In the future, the company will continue to be driven by "technology + internationalization," optimize its global supply chain layout, and contribute to the cause of human health.