Bailinke's disposable bags passed the DMF filing to help Chinese biopharmaceutical companies set sail to the sea

[Pharmaceutical Network Enterprise News] Recently, the single-use multi-layer co-extrusion bag produced by Bailinke has passed the US Food and Drug Administration DMF filing (FDA DMF filing number: 037110), and the type is three types of DMF--drug packaging materials, covering The products such as disposable liquid storage bags, stirring bags, cell bags and filling bags produced by Biolink, which means that customers using related products of Biolink can be submitted to the FDA in the regulatory filing documents for new drug registrati.
Directly cite DMF filings without the need to provide specific information on raw materials and excipien.
At the same time, the quality of the single-use multi-layer co-extrusion bag series products has been recognized internationally, which is a major milestone for Bailinke, which has laid a foundation for Bailinke to open the overseas market of biopharmaceutical disposable process consumabl.
As one of the main suppliers of key process equipment and consumables for biological products in China, Bailinke has always attached great importance to the construction of quality management syst.
At present, the company has passed the dual quality management system certification of "ISO9001:2015" and "ISO 13485:2016", and plans to introduce quality management systems such as GMP, ISO17025 and CMA in the future, and strive to create a comprehensive systematic, standardized, With a standardized quality system, it has become the most reliable long-term partner of domestic and foreign biopharmaceutical companies with high-quality and stable produc.
Scan the QR code below to get the relevant product details immediately: The meaning of DMF filing for single-use multi-layer co-extrusion bag series products DMF file (Durg Master Files, DMF) is the drug filing file submitted by the holder to the FDA, including drug products Confidential details of facilities, operating procedures, raw materials used in production, operation, packaging and stora.
According to the.

Federal Food, Drug and Cosmetic Act, the applicant must submit relevant applications to the FDA, such as clinical investigation application (IND), new drug registration (NDA) and biological product license application (BLA), e.
It is necessary to provide all the information on the safety, efficacy and quality of the drug, which involves the relevant technical content of APIs and excipients, but preparing these materials will undoubtedly consume a lot of time and energy, and the raw material suppliers are reluctant to Disclosure of their own technical information, thus seriously affecting the process of clinical applicati.
In order to solve this problem, FDA has established a DMF syst.
The raw material supplier directly submits the required technical content to the FDA in the form of DMF documents and obtains the record numb.
The drug applicant can directly use the DMF record number to replace the application proce.
Specific information on raw materials and excipients is required, greatly reducing review and evaluation ti.
About Bailinke Bailinke is a high-tech group enterprise that provides process solutions for the field of life sciences, focusing on the research and development and manufacture of key process equipment and consumables for vaccines, antibody drugs, cell therapy, gene therapy and other biological produc.
The products cover process units and process development services such as upstream cell culture of bioprocess, one-time preparation of stock solution and downstream chromatography, ultrafiltration, and filtrati.
Biolink is committed to continuously providing customers with high-quality innovative products and solutions, and creating an efficient, safe and competitive biopharmaceutical supply chain ecosyst.