US Drug Facility Registration and Renewal

Get a range of solutions for US Drug Facility Registration and Renewal from a single source. We assist you in the application process for establishment registration SPL and submitting it to FDA through ESG gateway.

US FDA Drug Establishment Registration

Drug Establishment Registration or FDA registration is mandatory for every facility. The activities that let facilities eligible for registration are manufacturing, packaging, testing, and propagation of finished bulk drugs. This means that every establishment involved in manufacturing, propagation, testing, and packaging finished and bulk drugs, including OTC and prescription drugs must be registered with FDA. FDA drug establishment registration process may take 4 to 5 working days.

Drug Facility Registration Renewal

FDA wants all domestic and foreign drug facilities to renew their registration every even numbered year. Facilities with no valid FDA registration risk refusal of imports of products by FDA or CBP. In addition, any foreign establishment is required to FDA registration. For this, they can appoint a US Agent for establishment registration or renewal purposes. The US Agent works as a point of contact for the FDA to communicate with the foreign facility. 

  • Drug Establishment site renewals are allowed every year (October 1 to December 31).  
  • Failure to renew in that time period may result in cancellation registration and the establishment will be removed from the FDA registration database.
Drug Facility Registration Renewal
Drug Facility Registration

Information Required for Drug Facility Registration

Below information is required by FDA to meet the Drug Facility Registration requirements.

  • Name of the company/facility/establishment
  • Address of manufacturing /Processing /Packaging /Testing facility
  • DUNS number for the establishment
  • Telephone, email and name of the contact person
  • US Agent information for foreign companies
  • Business operation information

Remember that Drug Facility Registration and FDA approval are two different aspects.

  • Registration is a mandatory requirement for manufacturing, testing, process, and packing facilities. 
  • FDA approval is required before a drug is imported into US.

How We Help in Drug Facility Registration and Renewal

Our former FDA officials help in preparing establishment registration SPL on behalf of your company and submit to the FDA through ESG gateway. If you are a non-US company, then we will serve as a US Agent service provider. If required, we will be available to work as a US agent for your company.

Required for Drug Facility Registration
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