International Registration Column | Basic Introduction to DMF in the United States

As the world's largest pharmaceutical production and sales market, the United States is the preferred market for many excipients companies to enter the international market. Division I has now completed a number of accessories varieties of the United States DMF filing, the following is the basic introduction of the United States DMF.

What is DMF?

Drug Master Files, or Drug Master Files, are archived pending data submitted to FDA that include detailed information about the manufacturing facilities, processes, quality controls, and all raw materials and packaging materials used in the manufacture, processing, packaging, storage, and distribution of human drugs.

Features of DMF

1.FDA only does formal review of DMF

2.FDA regulations do not require the declaration of DMF

3. The DMF on file with the FDA can support all users who use the product, and the DMF holder does not need to repeat the information to each user.

Classification of DMF

Type I:Production site, plant facilities and personnel

Type II:Intermediates, APIs and Pharmaceuticals

Type III:Packaging Materials

Type IV:Excipients, colorants, fragrances, flavors and other additives

Type V:Non-clinical data and clinical data

Main contents of DMF

DMF documents declared by pharmaceutical excipient manufacturers to the FDA belong toType IVThe main contents of the application documents include: relevant administrative information, enterprise commitment statement, description of physical and chemical properties of the application product, detailed description of product production process, product quality control and production process control, raw material quality control, quality research data, product stability, packaging and labeling, standard operating procedures, etc.

Submission of DMF

The eCTD(Electronic Common Technical Document) is a standard format for submitting applications, amendments, supplements, and reports to the FDA's Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

The DMF has the following statuses after submission:

“A” = Active.

“C” = Complete.

“I” = Inactive.

“P” = DMF Pending Administrative Filing review

“N” = Not an assigned number.

Hubei Gedian Renfu Medicine Auxiliary DMF Declared Varieties

Hubei Gedian Renfu Pharmaceutical Accessories Co., Ltd. has always adhered to the belief of becoming a global supplier of pharmaceutical accessories. Today, when the pharmaceutical accessories market is becoming more and more standardized, we take meeting the needs of customers as the foundation, and in the in-depth linkage with pharmaceutical companies, Pay attention to improving the application performance of accessories, and hope that while developing itself, it can also help the development and innovation of the accessories industry!

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