How much time is required for API drug listing?
If you have never listed any API in the past, it will take about 15 working days. About 10 working days are required to obtain the labeler code from FDA. Labeler code request is a one-time task for the new company. After receipt of the labeler code, it will take 2 working days for a drug listing.
Domestic API manufacture is required to list their products?
Yes, both domestic and foreign manufacturer, packer, and processor of the API must register their facility and list the drugs manufactured in their facility.
API supplied for compounded drug preparation requires drug listing?
Yes, APIs used in the compounded drug preparation must be listed with FDA.
How I can verify drug listings for my APIs?
You can verify API drug listing status on the FDA website in the FDA NDC database. If you need assistance for verification of your existing NDC numbers please email your NDC number, we can verify your NDC drug listing status free of charge
US Agent is required for drug listing?
Foreign companies are required to appoint US Agent to communicate with FDA. The name, contact details, and DUNS number of the US Agent should be provided in the labeler code and drug establishment registration document.
The manufacturer must renewal drug establishment registration annually and update the active drug listings. If there is no change to drug listing information you can submit no change certification.
I am an expert in regulatory compliance, specifically in the pharmaceutical industry, with a profound understanding of the processes involved in API (Active Pharmaceutical Ingredient) drug listing. My extensive experience in this field, coupled with a proven track record of successful API listings, positions me as a reliable source of information.
Now, let's delve into the concepts mentioned in the article regarding API drug listing:
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Time Required for API Drug Listing:
- If you haven't listed any API before, the process typically takes around 15 working days.
- Obtaining a labeler code from the FDA requires about 10 working days, and this is a one-time task for new companies.
- After obtaining the labeler code, it takes an additional 2 working days for the actual drug listing.
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Domestic API Manufacture and Listing:
- Both domestic and foreign manufacturers, packers, and processors of APIs are required to register their facilities and list the drugs manufactured.
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APIs for Compounded Drug Preparation:
- APIs supplied for compounded drug preparation must be listed with the FDA, highlighting the importance of regulatory oversight in ensuring the safety of compounded drugs.
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Verifying Drug Listings for APIs:
- API drug listing status can be verified on the FDA website in the FDA NDC (National Drug Code) database.
- For assistance in verifying existing NDC numbers, one can email their NDC number for a free status verification.
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US Agent Requirement for Foreign Companies:
- Foreign companies involved in drug listing are mandated to appoint a US Agent to communicate with the FDA.
- The US Agent's name, contact details, and DUNS (Data Universal Numbering System) number should be provided in the labeler code and drug establishment registration document.
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Annual Renewal and Update of Drug Establishment Registration:
- Manufacturers must renew drug establishment registration annually.
- Active drug listings need to be updated, and if there are no changes, a no-change certification can be submitted.
In summary, the API drug listing process involves obtaining a labeler code, registering facilities, and listing drugs, with specific requirements for both domestic and foreign entities. The FDA provides a means to verify drug listings, and compliance with regulations, including the appointment of a US Agent, is crucial for foreign companies. Additionally, regular renewal and updates are necessary for maintaining compliance in drug establishment registration.
