Zhejiang Jinguo Industry Co., Ltd. Secures FDA Drug Master File (DMF) Approval for Its Pharmaceutical Closures

In 2024, Zhejiang Jinguo Industry Co., Ltd. (hereinafter referred to as "Jinguo Industry") announced that its pharmaceutical closure products have successfully obtained a Drug Master File (DMF) number from the U.S. Food and Drug Administration (FDA). This milestone signifies that the product quality, production systems, and international capabilities of Jinguo Industry have earned authoritative recognition under the world’s highest regulatory standards, laying a solid foundation for the company to expand into global markets and deepen international collaborations.  

DMF Number: A "Passport" to the International Pharmaceutical Market

The DMF is a core certification for pharmaceutical products entering the U.S. and international markets, with its stringent technical reviews and compliance requirements regarded as the pharmaceutical industry’s "gold standard." Jinguo Industry’s acquisition of the DMF number not only validates the full-process compliance of its operations—from raw material procurement and production processes to quality control—but also highlights its leading position in the research, development, and manufacturing of pharmaceutical materials. Moving forward, international clients can directly reference the DMF file to support drug approval applications, significantly accelerating market entry timelines.  

Quality-Driven Global Competitiveness

Jinguo Industry has always adhered to the philosophy of "innovation-driven growth, quality-first excellence," establishing a modern production base compliant with cGMP (current Good Manufacturing Practice) and continuously investing in cutting-edge R&D and production system upgrades. The approval of the DMF file is the inevitable outcome of the company’s years of dedication to the pharmaceutical packaging sector and strict adherence to international standards, providing clients with safer and more reliable supply chain solutions.  

Global Expansion, Empowering Partnerships

Leveraging its FDA DMF certification, Jinguo Industry will further strengthen collaborations with international pharmaceutical companies, biotech firms, and overseas packaging suppliers, delivering high-quality, cost-effective products and customized services to global clients. The company plans to assist partners in enhancing R&D efficiency, reducing compliance costs, and jointly advancing the globalization of innovative drugs.  

Looking Ahead: Continuous Innovation, Partnering with the World

Jinguo Industry will seize the opportunity presented by this FDA certification to further optimize its quality management systems, increase R&D investments, and promote sustainable pharmaceutical technologies, striving to become a trusted partner in the global pharmaceutical supply chain. The company looks forward to collaborating with domestic and international enterprises to benefit more patients through premium products and services, contributing Chinese expertise to global healthcare.  

About Zhejiang Jinguo Industry Co., Ltd.

Zhejiang Jinguo Industry Co., Ltd. specializes in the R&D, production, and sales of medical closures. As a national high-tech enterprise and provincial-level "specialized and sophisticated" SME, its product portfolio includes components for pre-filled syringes, cartridge vials, lyophilized, powder, and infusion closures, oral liquid caps, and blood collection devices. With a global vision, Jinguo Industry is committed to becoming a world-class pharmaceutical packaging manufacturer and service provider. **Our mission is to be the world’s most trusted supplier of safe closures.  

Contact Us

Website: www.chinajinguo.com  

Tel: +86-18217587037  

Email: shi@chinajintai.com  

— Zhejiang Jinguo Industry: Quality as the Foundation, Recognized Globally  

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