Jiangsu RealTop disposable bag related products through DMF filing
- NEWS-
Jiangsu RealTop disposable bag through the United States Food and Drug Administration (FDA) of the DMF(Drug Master File) for the record. (Record No.: DMF037894)
2023
spring, the footsteps of the year of the rabbit, the bell of the year of the rabbit, the happy note in your heart, luck and peace, such as the footsteps of spring closely follow! Chunhua Qiushi, Ruituo will always be with you!
the first good news after the 2023 Spring Festival--Jiangsu RealTop disposable bag through the United States Food and Drug Administration (FDA) of the DMF(Drug Master File) for the record. (Record No.: DMF037894)The filing includes mixing bags, liquid storage bags, filling bags, sampling bags and other related products.
(official certificate)
When future customers use RealTop's disposable products for the U. S.-China double report project,can directly refer to this filing without the need to provide additional specific information, which helps shorten the time for data preparation, review and evaluation.
About DMF
Drug Master File (DMF) is the drug file that the holder submits to the FDA,contains confidential details of the facilities, operating procedures, raw materials, etc. used in the manufacture, handling, packaging and storage of the drug product.
According to the regulations of the US Federal Food, Drug and Cosmetic Law, the applicant must submit relevant applications to FDA before the drug is put on the market, such as clinical research application (IND), new drug registration (NDA) and biological product license application (BLA), and need to provide all the information of the drug in three aspects of safety, effectiveness and quality, including the relevant technical contents of raw materials and excipients, however, the preparation of these materials will undoubtedly consume a lot of time and energy, and the raw material suppliers are unwilling to disclose their own technical information, thus seriously affecting the process of clinical declaration.
to solve this problem,FDA establishes DMF system, the raw material supplier submits the required technical content directly to the FDA for filing in the form of a DMF file and obtains a filing number,drug filers can directly use the DMF filing number to replace the need to provide specific information about raw materials and excipients in the filing process, greatly shortening the review and evaluation time.
About RealTop Biotechnology
High standard workshop to provide customers with high quality products
Jiangsu RealTop Biotechnology Co., Ltd. is a high-tech enterprise located in Linjiang New District, Haimen District, Nantong City, Jiangsu Province. It is mainly engaged in the development, production and sales of biological disposable products. The company has a number of disposable products related to patented technology. The products are mainly used in the field of biopharmaceutical and cell therapy, such as storage, transportation, filling, sampling, aseptic connectors, etc., so as to help biotechnology, pharmaceutical enterprises and medical related enterprises to better comply with the new GMP, environmental protection, EHS requirements and medical regulations.
