FDA Drug listing requirements for API (bulk drugs)
Drug establishment registration and drug listing are mandatory requirements for APIs (bulk drugs) commercially marketed in the USA. Manufacturer of API must register their drug establishment where the product is manufactured, packed or processed and list all the drugs which are in the commercial distribution. What information is required for API drug listing ? Below … Continue reading FDA Drug listing requirements for API (bulk drugs)
What are your fees for drug listing?
Our fees for drug listing are $250.
What are your fees for NDC assistance ?
Our fees for NDC number assistance are $199.
What information do I have to provide for Drug Listing?
For drug listing, we need the following information: Product label Labelling information Packaging configuration FEI number
How can you help me with Drug Listing?
We provide a complete service for drug listing and NDC numbers. We will support you through each stage of the process, until your registration is complete.
How much time will Drug Listing take?
Once we have the information, the process takes two to three days.
How much time does it take to obtain the NDC number?
This process takes around 48 hours.
Who needs a Drug Listing?
The owner or operator of an establishment entering into drug manufacture or preparation.
What Is NDC Number?
What is NDC Number (National Drug Code) ? NDC number is 10 digit numerical code assigned to drugs. First 5 digits of the NDC number come from the labeler code. Labeler code is assigned by the FDA to manufacturer , distributor or brand owner of the product. The first step for NDC number is to obtain … Continue reading What Is NDC Number?
What is a Drug Listing?
Drug listing is the process of providing product and labeling information to FDA in electronic format.
What is the Labeler Code?
This is the number assigned by the FDA to the manufacturer /packer/labeler of the drug.