Applitech Haimore® series disposable co-extrusion bags officially completed DMF filing 原创 艾贝泰 艾贝泰 2023-12-20 17:43 广东 Original Aibeitai Aibeitai 2023-12-20 17:43 Guangdong

Recently, Haimore® series of disposable co-extrusion bags owned by Applitech successfully passed the review of FDA of the United States Food and Drug Administration and completed the DMF filing of Class III drug packaging materials, filing number: 038764. In the future, users who use the Applitech Haimore® series of disposable co-extrusion bags, including disposable storage bags, sampling bags, filling bags, etc., can directly cite relevant filings through us when submitting regulatory filings for new drug registration to FDA. Effectively shorten the preparation time of materials and documents related to such products in the process of raw materials and excipients submission review and evaluation of product application, and accelerate the process of drug application.

Applitech factory has been adhering to the requirements of standardized production management of high-quality system. While paying attention to the stable mass production of products already on the market, it has continuously innovated and made progress. In recent years, it has independently developed a series of products such as liquid storage platform, packaging system, Abio™ series thermoplastic tube sealing machine, freeze-thaw protection, aseptic sampling system, etc. For more biopharmaceutical industry users, provide high-quality, competitive disposable fluid solutions.