How can I register my drug facility production?


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The food and Drug Administration is a company that overlooks all food products as well as drugs and their benefits for the social health of humans. They oversee all kinds of processes related to drugs and food such as manufacturing, processing, packaging, and selling





Registering with the FDA

Nowadays it is mandatory for all food as well as drug pharmaceutical shops to register with the FDA. If any manufacturing company is not registered with the FDA, their products may be rejected right away before even selling in the stores. The Food and drug administration Act requires that all kinds of drug establishment be included in the FDA drug listing documents. All information about drugs, their ingredients, their date of manufacture and process needs to be electronically submitted.

Facilitating submission of drugs

In order to facilitate the submission the FDA Drug Establishment Registration in USA as well as drug listing information, the FDA has adopted the use of extensive language  files and Technical File in a standardized format. Currently, all drug establishments whether they are foreign or domestic must register all their establishments as well as drug listings and products in the United States. The FDa helps in over looking the packaging of the product along with labeling, compounding, processing and propogation. They must register their establishement within 5 days after beginning the operation.


Submitting  the form

Registrants need to submit a registration form  for all their extablishments and apart from that, they also must follow the 21 CFR 820 that looks into the various processes of registration and rules and regulation of following a standard quality in the FDA. If a company is not registered with the FDA then all the  products can be rejected  under the section 21 CFR 820 of the food and registration act. All owners, operators as well as foreign facilities that manufacture drugs and food require a FDA Drug Establishment Registration number to stand in the market.

The basics of a drug master file

The Drug master file Submission is  file that is submitted by all pharmaceutical as well as food companies to the FDA stating their various methods of food manufacturing, the process, packaging, allocation, storage and various other methods that follow the standard rules of the FDA. It covers all the most minute  details about different facilities and processes followed by the manufacturing companies. The technical contents of a Technical File are reviewed in connection with an export application. US FDA DMF are more often than not  provided for in 21 CFR 314.420 and the guidelines also discuss the various kinds of DMF files as well.

Contents in a DMF file 
A DMF file contains a transmittal letter with all kinds of administrative information about different submissions that needs to be submitted to the FDA.It helps to describe all kinds of domestic facilities. All products require a FDA registration number which is very important.The FDA number helps the company to sell all is drugs as well as food products and tobacco related good as well without any kind of obstrusions