International Recognition | HySum's Oral Solid Pharmaceutical HDPE Bottle Receives DMF Registration

Recently, HySum's subsidiary, Suzhou Qingyi Pharmaceutical Packaging Co., Ltd. has successfully registered its self-developed high-density polyethylene (HDPE) oral solid pharmaceutical bottle with the U.S. Food and Drug Administration (FDA) under Drug Master File (DMF) number 039204.

Qingyi Pharmaceutical Packaging is a qualified company under HySum, specialising in the production of pharmaceutical-grade low-density polyethylene (LDPE) films, pouches and oral solid HDPE bottles. It is one of the first companies approved by the National Medical Products Administration (NMPA) to manufacture these products. The company is committed to providing high quality pharmaceutical grade raw materials and semi-finished product protection solutions, ensuring that quality medicines are paired with excellent packaging from the start of the production process.

A Drug Master File (DMF) is a submission to the FDA that provides detailed information on the manufacture, processing, packing, storage and wholesale distribution of human drugs. This includes details of production facilities, processes, quality control and raw materials used. In countries such as the United States, only DMF-approved materials, devices and technologies can be used for commercial clinical applications.

The product approved in this DMF submission is the HDPE bottle for solid oral dosage forms. HDPE resin is non-toxic, tasteless, odourless and highly crystalline, with higher density, excellent mechanical strength, heat resistance and good solvent and water vapour permeability. These properties meet pharmaceutical packaging requirements such as water vapour and solvent resistance, non-toxicity, tastelessness, odourlessness and good toughness.

This DMF registration offers several benefits and conveniences to customers using HySum's HDPE oral solid pharmaceutical bottles:

1. Applicants for different pharmaceutical products using the same HySum DMF registration number do not need to undergo multiple reviews, saving evaluation resources.
2. Pharmaceutical applicants using HySum's oral solid HDPE bottles can refer directly to the DMF registration number when submitting their registration dossiers, simplifying the formulation application process and accelerating the drug approval timeline.
3. A team of professional materials and mould engineers is available to support product development.
4. Dedicated business professionals track project progress, ensuring short development cycles and high flexibility.

DMF registration is a significant qualification for HySum's oral solid pharmaceutical HDPE bottles and marks a milestone in obtaining certification from the world's leading international medical and health regulatory authorities. This achievement further advances HySum's path towards global quality standards and service internationalisation, and opens a new chapter for Qingyi Pharmaceutical Packaging's global commercialisation.

HySum is also in the process of applying for FDA DMF registration for other products and will continue to invest in continuous innovation in materials, processes and quality control technologies. Through higher quality and more stable services, HySum is committed to helping customers meet the growing demand for superior pharmaceutical packaging.