Basic introduction to American DMF

As the world's largest pharmaceutical production and sales market, the United States is the first choice for many excipient companies to enter the international market

Drug Master Files, or Drug Master Files, are archived materials submitted to the FDA for review.

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Type I: production location and plant facilities, personnel

Type Ⅱ: Intermediates, APIs and drugs

Type Ⅲ: Packaging materials

Type IV: auxiliary materials, coloring agents, spices, flavors and other additives

Type V: Non-clinical data and clinical data

The DMF file declared by the pharmaceutical excipient manufacturer to the FDA belongs to Type IV .

eCTD (Electronic Common Technical Document) is a standard format for submitting applications, amendments, supplements and reports to the FDA Center for Drug Evaluation and Research (CDER) and Center for Biological Products Evaluation and Research (CBER)
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After the DMF is submitted, there are the following states:

"A"= Active.
 

"C"= Complete.
 

"I"= Inactive.
 

"P"= DMF Pending Administrative Filing review 

"N"= Not an assigned number.
 

Hubei Gedian Renfu Pharmaceutical Excipients Co.
, Ltd.
always adheres to the belief of becoming a global supplier of pharmaceutical excipients.
Today, as the pharmaceutical excipients market is becoming increasingly standardized, we are fundamental to meeting the needs of our customers, and we are deeply connected with pharmaceutical companies.
, Attach importance to improving the application performance of auxiliary materials, and hope that while developing itself, it can also help the development and innovation of the auxiliary material industry!