News

LePure Biotech’s single-use bags have been granted US FDA Type III DMF filing number

July 14, 2022, Shanghai, China

LePure Biotech has successfully filed and obtained the US FDA Type III DMF filing number.

A Drug Master File (DMF) is a document that is independently submitted to FDA by the manufacturer, containing information on the production, process control, raw materials, applicability, quality control and the like of the product. There are five types of DMFs, of which Type III involves the packaging material – container.

The US DMF file library is a widely referenced supplier repository for pharmaceutical manufacturers worldwide, and the completion of DMF filing provides following advantages:

- Companies that have obtained filing numbers and their products will be displayed on the FDA website, allowing them to build partnership with more pharmaceutical manufacturers;
– Companies holding the DMF filing numbers granted by FDA can be given priority by pharmaceutical manufacturers in the competition with other companies, thereby gaining a competitive advantage;
– FDA may update information at any time as required by the filed companies;
– The risk of leakage of company’s confidential technology as a result of providing information to numerous pharmaceutical customers can be reduced;

In particular, for a pharmaceutical manufacturer who submits a registration application to FDA, the DMF filing number can be directly referenced in the relevant section of the dossier, which simplifies the application.

So far, the single-use bags corresponding to LeKrius®, LeRybow® and LeRugia® of LePure Biotech have completed the DMF filing and been granted DMF filing numbers.

LePure Biotech is constantly exploring the international market and is committed to becoming a trusted partner of global biopharmaceutical companies.


Post time: Aug-04-2022