US FDA Drug Establishment Registration

This is not FDA Website. We are consultants and USFDA Agents helping manufactures and Exporters across the globe to register and List the products with US FDA.

Readers are requested to read more about USFDA Drug Registration and Listing regulation before starting the activities.

We provide service for the following category of Products

  • OTC Drugs [ Those Drug molecules listed in the OTC monograph are only considered]
  • API Manufactures [ all kind of pharma API’s included]
  • Homeopathic [ All kind of homeopathic medicines]
  • Testing Laboratories [ Laboratories testing OTC and Generic Drug products for Human and Clinical trial purpose]
  • Medicated Lotions, Creams and other external preparation [ considered as cosmetics in various countries]

Important things on Drug Establishment Registration process

Your Drug Establishment / Facility must have atleast one Listing to keep Registration and NDC Number / Labeller Code active.

The below table explains each of the steps one by one.





Submit Filled Application Form online


Need Expert  Guidance ?

150 USD


US Agent fees for the initial year

600 USD


Verification of DUNS Data  



Drug Establishment Registration

100  USD


NDC Number / Labeller Code Request


SPL Preparation and Submission


Verify Registration Status with US FDA



Submit Labels of every dosage form


Need our expert assistance ?

650 USD


Submit Application for Drug Listing

400 USD

Need our expert assistance

50 USD


Verify your Listing Details


Payments made from USA

Drug Registration & Listing

Payments made from INDIA

Drug Registration & Listing

Payments made from Other Countries

Drug Registration & Listing

BILLING / PAYMENT assistance write to


Experts from our company will understand your product, guide you correctly considering all the possible errors which can happen during filling. Our support ends with successful submission of Application Form till registration is completed.

NO. You can make payments stage by stage ( for example; make payment for Stage 02 once stage 01 is completed and you are satisfied with our service.

Your product label should comply with FDA regulation for sure!, but you can try getting the guidance from other reliable sources. In case you need to our expert service you need to buy this service.

If any of the above contains Medicines as one of the major active ingredient, it is as Drug not a cosmetic technically, so drug establishment registration and Listing is mandatory.

More information

INDIA – Bangalore
+ 91 994 591 2081
Phone / Viber / WhatsApp

USA – Chicago
+1 630 696 1293
Phone / Viber / WhatsApp

GERMANY – Bremen
+49 2161 990 8831
Phone / Viber / WhatsApp