Recently, Pinshan Biotechnology (Shanghai) Co., Ltd. (hereinafter referred to as "Pinshan Biotech") has successfully obtained the US FDA DMF Type II filing (filing number: 040976) for its independently developed and declared HiFTra™ PEI transfection reagent product.
This marks another international recognition of Pinshan Biotech's strength in the biotechnology and biopharmaceutical fields. The DMF filing obtained for HiFTra™ PEI transfection reagent is the third DMF filing for Pinshan Biotech after CulClear™ Depth Filters and CiDao™ Ceramic Hydroxyapatite, marking a milestone for the company.
Customers using Pinshan Biotech's HiFTra™ PEI transfection reagent can directly reference this DMF filing when submitting regulatory filing documents for new drug registration to the FDA, thereby simplifying the application process and shortening review and evaluation times.
Pinshan Biotech: Committed to To Be a Global Innovative Leader in Biopharmaceutical Process Solutions.
PinShan Biotech has been focusing on the research, development, production, and sales of core consumables for biotechnology and biopharmaceuticals, dedicated to promoting continuous optimization of bioprocesses and integration of upstream and downstream industries. With a strong accumulation of independent intellectual property rights and solid research and development capabilities, Pinshan Biotech's product line covers key aspects such as cell culture, filtration, and chromatography, providing global customers with one-stop, customized solutions for biopharmaceutical consumables.
Excellent Quality: Rigorous Quality Management System
Pinshan Biotech attaches great importance to the establishment and improvement of its quality management system. All our production bases strictly follow GMP standards for biological drugs in production management and have successfully obtained ISO9001 quality management system certification. We strive to create a comprehensive, systematic, standardized, and normalized quality management system to ensure the quality and stability of each product, winning wide recognition in the market with our excellent product quality.
Product Introduction: HiFTra™ PEI Transfection Reagent
HiFTra™ PEI transfection reagent is a high-performance transfection reagent independently developed by Pinshan Biotech, featuring high efficiency, high stability, and low toxicity. It is widely used in gene therapy, cell therapy, vaccine research and development, and other fields. Obtaining the FDA DMF filing further validates the excellent technical and quality performance of HiFTra™ PEI transfection reagent, marking the international certification of Pinshan Biotech's research and development capabilities and product quality in the biomedical field.
About DMF Filing
Drug Master File (DMF) is a confidential document submitted by a drug raw material supplier to the US Food and Drug Administration (FDA), mainly containing key information such as drug raw materials, production processes, control standards, packaging, and storage. The purpose of DMF filing is to help drug applicants simplify the data submission process when submitting new drug application files to the FDA. By referencing the filed DMF document, drug developers do not need to provide detailed information on raw materials, thereby accelerating the review and approval process for new drugs.
DMFs are classified into five types, with Type II DMFs mainly involving drug raw materials, excipients, and their manufacturing processes. DMF filing is an important recognition by the FDA of a supplier's quality, technical, and regulatory compliance. Companies with DMF filings are generally regarded as having higher credibility in the industry and demonstrating greater reliability in meeting cGMP requirements.
