FDA Drug Establishment Registration

FDA's Centre for Drug Evaluation and Research (CDER) is evaluating and approving new drugs before they are sold in the US. If your company is interested in selling prescription and non-prescription or over-the-counter (OTC) drugs, here are the guidelines for registration with the US FDA:

  • Companies must submit a New Drug Application (NDA) to introduce a new drug product into the U.S. Market.
  • After the patents or other periods of exclusivity on brand-name drugs, manufacturers / sponsor can submit an Abbreviated New Drug Application (ANDA) with FDA.
  • OTC drugs can be brought to the market, if OTC drug conforming to a monograph can be marketed without FDA pre-approval, just by FDA drug Establishment Registration and Listing.

We can help the following type of Drug manufacturers to sell the products in the US Market by completing US FDA Drug Registration (facility Registration / Establishment Registration).

  • OTC Drugs
  • Drug Testing Laboratories
  • Dietary Supplement
  • Homeopathic Drug
  • Active Pharmaceutical Ingredient (API)

Following steps must be done by the drug manufacturers for the FDA Drug Establishment Registration (Drug Facility Registration):

The FDA Drug Facility Registration can be completed in 3-7 days and Drug Listing 10-15 working days.

If interested in FDA Drug Facility Registration please fill the above form and submit Online.

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