What is a Drug Master File?

When talking about the Drug Master File,different manufacturers have different reactions.The DMF is not mandatory for manufacturers to register.However,a large number of drug manufacturers still apply for and register DMF for their products.Why?

What is a Drug Master File?

To get down to business,let’s take a look at the contents of the Drug Master File first,and then talk about what it can do!

A complete set of documents reflecting drug production and quality management is called the Drug Master File(DMF),which includes the introduction of the manufacturing site(plant),specific quality specifications and inspection methods,production process and equipment description,quality control and quality management.

Which companies can apply for DMF?

There are FIVE types of DMF issued by FDA:

Type I:Manufacturing Site,Facilities,Operating Procedures,and Personnel

Type II:Drug Substance,Drug Substance Intermediate,and Material Used in Their Preparation,or Drug Product

Type III:Packaging Material

Type IV:Excipient,Colorant,Flavor,Essence,or Material Used in Their Preparation

Type V:FDA Accepted Reference Information

According to the above five types,different types of companies can apply for them according to their own needs for the information content required by different types of DMF.

For example,if you are an API manufacturer,the DMF you need to apply for from FDA belongs to Type II.The materials you provide should include:application submission,relevant administrative information,enterprise commitment statement,description of physical and chemical properties of the applied product,detailed description of product production methods,product quality control and production process control,product stability test,packaging and labeling,standard operating procedures Storage and management of raw materials and finished products,document management,verification,batch number management system,return and disposal,etc.

In most cases,the DMF has become one of the important factors for a certain type of drug and API whether they can be exported to a certain country.When you want to enter the sales market of other countries,the availability of this DMF is crucial.

Just like in the European Community,DMF is part of the marketing license.For drugs,a set of materials shall be submitted to the European Community or the National Drug Administration of the selling country,and the marketing license shall be handled.When the supplier of the active ingredient(i.e.API)used in the drug changes,the above procedures shall apply.DMF is an important part of the application materials.If DMF is not provided as required,the products produced cannot be sold to the country.

DMF plays a key role for manufacturers.At present,Hande is applying for Melatonin DMF.In terms of document registration,Hande has many years of application experience and a professional team.The Rapid Response Center we have provides you with the best options to meet your needs in the shortest time.If you need to apply for DMF documents while ordering Melatonin,please feel free to contact us!


Post time: Sep-23-2022