Drug Establishment Registration with FDA

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.
  • Afer 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 below type of manufactures to sell the products in US Market by completing FDA Registration (facility Registration / Establishment Registration).

  • OTC Drug
  • Drug Testing Lanboratories
  • Dietary Supplyment
  • Homeopathic Drug
  • Active Pharmaceutical Ingredient (API)

The following are the steps for FDA Drug Establishment Registration

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

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

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