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Zhuhai Maidfa has successfully passed the dual filing and master file filing of DMF and device MAFs in the United States!
Source:
Date:2024-03-26

Recently, the medical-grade PHA raw materials independently developed by Zhuhai Maidefa Biotechnology Co., Ltd. (hereinafter referred to as "Zhuhai Maidefa") have successfully obtained the dual filing of DMF and MAFs from the U.S. Food and Drug Administration (FDA), with record numbers of DMF039347 and MAF3790 respectively.

At the same time, in the State Food and Drug Administration, Zhuhai Maidefa also successfully obtained the second master file filing, record number: M2023190-000. In the future, domestic and foreign customers who use Zhuhai Maidefa medical-grade products can directly quote the relevant record number in the documents submitted for new drug or device registration, which greatly shortens the product review and evaluation time, simplifies the application process, and accelerates the project application process.

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At present, according to different needs, Zhuhai Maidfa can provide the following specifications of medical grade PHA raw materials:

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