Drugs Companies that export medicines to the United States must register with FDA and obtain approval if necessary.
The American Technology Clinical Solutions Inc. consults FDA-related work for companies that want to export to the U.S. for social contribution and, if necessary, deputizes FDA registration, inspection, approval, and agents through a trusted research institute in the U.S.
Pharmaceutical companies exporting to the United States shall comply with the requirements and regulations of the Federal Food, Drug, and Cosmetics Act and Title 21 of the Code of Federal Regulations (21 CFR: 21). These requirements and regulations require new medicines and abbrev(shortened) new medicines, labeling, drug listing, and manufacturing in accordance with Current Good Manufacturing Practices (CGPM). It also includes registration of medication facilities.
Items Required for Medication Facility Registration
U.S. agent registration is mandatory when registering medication facilities.
| 1 | The name and DUNS number of the establishment |
| 2 | The Address of the establishment |
| 3 | Contact Information |
| 4 | The name and DUNS of a U.S. agent |
| 5 | The name and DUNS of all importers |
Registration period
About a week or three
Validity period
Until December of the following year after registration
Agency work
- Open CDER Direct Account
- Registration of medication facilities and handling of all tasks
- U.S. Agent Registration and Cooperation
- Acting as Emergency Contact
- Notify me that I need to extend before the expiration of my term.
Label codes are used to generate the National Drug Code (NDC) for medicines. Drug facility registration companies list products to be sold with their label codes to FDA.
NDC Code example
Each of the medications requires an independent 10-digit NDC code, as shown in the example of an NDC code above, and the medicines from the same pharmaceutical manufacturer will have the same Label Code.
Items Required for Product Listing
| 1 | Full 10-digit NDC |
| 2 | Proprietary and non-proprietary name |
| 3 | Dosage form and route of administration |
| 4 | The name and amount/strength of each active ingredient |
| 5 | Each inactive ingredient only |
| 6 | A copy of the most up-to-date labeling, including a JPG file of the outer packaging and principal display panel |
| 7 | The name and DUNS number for each establishment involved in manufacturing the product |
Registration period
About 1 to 3 months
Validity period
Until December of the following year after registration
Agency work
- Open CDER Direct Account
- Forming a label code and listing products to handle all tasks
- Acting on other inquiries to the FDA
OTC Drug is an over the counter drug that can be purchased without a doctor's prescription. OTC registration can be checked on the FDA's Monograph, and each Monograph tells you what active ingredients you need to be able to register. Currently, there are about 100 OTC Monographs, and the total number of active ingredients is 1,700 depending on the purpose of use.
OTC Drug example
Medications that are generally available at pharmacies without a doctor's prescription, such as sunscreen, BB cream, atopic treatment lotion, toothpaste, acne treatment, dandruff treatment, weight control, trauma treatment ointment, and eye removal agents.
Registration period
Non-drug items vary depending on the drug for approximately one to three weeks and may take months to years clinically. This is where you need to consult with your researcher.
Agency work
- Open CDER Direct Account
- OTC Drug Registration All Business Processes
- Active Ingredient, Monograph OTC registration status check
- U.S. Agent Registration and Cooperation
- Labeling consulting on OTC products
CS Center
Tel 916) 940-8899 E-mail atcs@atcsfda.com
ATCS, AMERICAN TECHNOLOGY CLINICAL SOLUTIONS, INC
The office is being relocated.