Xinfuda Cyclic Olefin Polymer Medical Plastic Bottle Passed the U.S. DMF Record

The U.S. Food and Drug Administration has formally informed Shijiazhuang Xinfuda Medical Packaging Co., Ltd. that Xinfidelity cyclic olefin polymer medical plastic bottles (referred to as COP bottles) have obtained the US DMF filing, with the filing number: 035292.

5ml COP vial

U.S. food and drugs implement a strict DMF filing system. According to the Federal Regulations of the United States, drugs and related products entering the United States must apply for registration with the US FDA and submit a management file (DMF). Obtained the DMF registration qualification approved by the U.S. Food and Drug Administration, and can be legally sold in the United States, which means that Xinfuda's research and development capabilities have improved. COP vials have reached international standards in terms of production quality and technology research and development. 

The Xinfuda COP vial is made of raw materials imported from Japan and is formed by ASB equipment at one time. It has good chemical barrier properties, high transparency, not easy to change color after radiation, and does not peel off with strong alkali tests. It is suitable for high protein adsorption requirements Or drugs that are easy to produce glass peeling, the quality of which can compete with the international market.

For many years, it has been Xinfuda’s constant pursuit to go to the international market and serve major international customers. As early as 2015, Xinfuda had mastered the COP bottle production technology and achieved mass production. In 2018, it passed the CDE filing (registration number: B20180001378) ), in 2020, it began to conduct related reviews with CSPC, and has been at the forefront of the industry in terms of product development.

Filing through the US DMF is a powerful explanation for Xinfuda to promote development through research and development. The company will continue to enhance its core competitiveness in product development and provide customers with high-quality products and services.