• How to get US FDA Drug Import License?
  •  Every company who want to import drug license from US
  •  Needs to be FDA Import Drug License
  •  It’s mandatory to have licence since 2004
  •  FDA Provides guidelines to get FDA Import License
  •  All provided guidelines has to be fulfilled
  •  It takes 90 days to get FDA Import license
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  •  Fill the online registration form
  •  Make One Time Payment
  •  Our team collects all documents
  •  Dedicated A/C Manager Assigned for your work
  •  Weekly Update for your work
  •  Your US FDA Drug Import License Register Completed.
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To import drugs into the United States, you must comply with the regulations set by the U.S. Food and Drug Administration (FDA). The FDA does not issue a specific “Drug Import License” but requires drug importers to register their establishments and follow specific procedures. Here’s an overview of the process for drug importation:

1. Establish DUNS Number: Before registering with the FDA, you may need to obtain a Data Universal Numbering System (DUNS) number, particularly if you are not already registered with the FDA. The DUNS number is provided by Dun & Bradstreet and may be required for FDA registration.

2. Register with FDA: Drug importers must register their establishments with the FDA through the Drug Registration and Listing System (DRLS). This registration includes details about your business and import activities.

3. Obtain National Drug Code (NDC): If you are importing drugs for commercial distribution in the United States, you will need to obtain a National Drug Code (NDC) for each drug product. The NDC is a unique identifier for drugs, and it is required for listing the drug with the FDA.

4. Comply with Drug Labeling Requirements: Imported drugs must comply with FDA labeling requirements, including proper drug identification, instructions, and warnings. The labeling should be in English, and any foreign language labeling should have an English translation.

5. Adhere to Good Manufacturing Practices (GMP): If you are importing drugs for commercial distribution, ensure that the foreign drug manufacturing facilities follow Good Manufacturing Practices (GMP) or their equivalent as required by the FDA.

6. Submit Drug Listing Information: All imported drugs must be listed with the FDA. This includes providing detailed information about each drug, including its NDC, packaging, and labeling.

7. Address Drug Importation Compliance Issues: The FDA may inspect drug importers’ facilities and review their importation processes to ensure compliance with FDA regulations. Address any issues or observations raised during inspections promptly.

It’s important to note that the drug importation process can be complex, and specific requirements may vary depending on the type of drugs being imported and the intended use. For detailed instructions and requirements, refer to the FDA’s official website (www.fda.gov) and consult relevant guidance documents. Additionally, seeking the assistance of regulatory experts or consultants familiar with drug importation and FDA regulations can be helpful in navigating the registration and importation process successfully.https://www.corpregistered.com/fdaconsultingimport

To register with the U.S. Food and Drug Administration (FDA), the specific requirements and processes will vary depending on the type of business and the products or services you provide. Here is a general overview of the FDA registration process:

1. Determine Applicability: Identify whether your business or product falls under FDA regulation. The FDA oversees a wide range of products, including food, drugs (including prescription and over-the-counter medications), medical devices, dietary supplements, cosmetics, and more.

2. Obtain a DUNS Number: If your business is not already registered with the FDA, you will need to obtain a Unique number. This unique identifier and is required for certain FDA registrations.

3. Determine the Appropriate FDA Registration: Depending on your business and the products you deal with, you may need to register with specific FDA programs. For example:

   a. Food Facilities: If you are involved in food manufacturing, processing, packaging, or storing, you may need to register as a food facility with the FDA.

   b. Drug Establishments: If you manufacture, distribute, or package drugs (including over-the-counter medications), you may need to register as a drug establishment.

   c. Medical Devices: Manufacturers, distributors, and importers of medical devices are generally required to register their establishments and list their devices with the FDA.

   d. Dietary Supplements: If you manufacture or distribute dietary supplements, you may need to register with the FDA as a dietary supplement facility.

4. Complete the FDA Registration: Once you have determined the appropriate registration category, you will need to complete the registration process. This typically involves submitting an online application through the FDA’s registration portal, providing the necessary information about your business, products, and manufacturing processes.

5. Pay the Registration Fee: Depending on the specific FDA program and type of registration, there may be a fee associated with the registration process. Ensure you review the FDA’s fee schedule and make the necessary payment.

6. FDA Inspection (if applicable): Certain businesses may be subject to FDA inspections to verify compliance with regulatory requirements. This is more common for food facilities, drug establishments, and medical device manufacturers.

It’s important to note that the FDA registration process can be complex, and requirements can change over time. It is recommended to consult specialist and relevant guidance documents specific to your industry to ensure compliance with the most up-to-date regulations. Additionally, you may consider engaging with legal or regulatory experts familiar with FDA requirements to assist you with the registration process.