How to get NDC number
The first step to get the NDC number is obtaining a labeler from the FDA and then the NDC number can be assigned to products using the labeler code obtained by the FDA. In this article, we have answered your questions about how to get NDC numbers in detail. Step by step guide on how… Read More
What is FDA DMF ? US FDA DMF Filing
FDA Drug listing requirements for API (bulk drugs)
What should you know about DMF annual report
eCTD Requirements and cost effective solutions
How much is the DMF Fee ?
DMF fee is applicable only for type II DMFs (API or Drug Substance). There is no fee charged by FDA for packing material or excipient DMF. FY 2019 , DMF fee is $ 55,013. This fee should be paid well before referencing your DMF in your ANDA application. However, you can still submit the… Read More
How much time is required for DMF submission?
How we can assist for DMF submission to FDA?
Pragmatic offers a complete solution for all types of DMF submission to the FDA. We offer DMF review, compilation, technical gap analysis, eCTD conversion and submission through ESG. We also provide services for management throughout the lifecycle of a drug master file. Please contact us for more information.
What is a Drug Master File?
A Drug Master File – or DMF – is FDA’s provision to submit confidentiality information on the chemistry, manufacturing and control information about a product for the agency’s evaluation.
Our Services for GDUFA Self Identification Requirement
When Should I Self-Identify?
You should self identify if you are performing generic drug-related activities, including manufacturing, testing, or clinical studies. It is more important to know when you should self identify. Our services can save you time and money.
How much time will it take to self-identify my facility?
With our support, the self-identification process takes about 48 hours.
How can I very my self-identification status?
The FDA publishes a list of all self-identified facility addresses, along with their type of business.
What information is required for self-identification?
What about fees for self-identification?
Only facilities that manufacture, or intend to manufacture, generic drug APIs, FDFs, or both, are required to pay facility fees. Sites and organizations that only perform testing, repackaging, or re-labelling are not required to pay a user fee.
Who needs to self-identify?
All facilities involved in generic drug manufacturing (including API manufacturing), packing, testing and bio-equivalence testing are required to self-identify.
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?
How much time will Drug Listing take?
How much time does it take to obtain the NDC number?
Who needs a Drug Listing?
What Is an NDC Number? FDAbasics.com – Drug Listing
What is a Drug Listing?
Drug listing is the process of providing product and labeling information to FDA in electronic format.
What is an NDC labeler code? FDAbasics
When do we need to renew Drug Establishment Registration?
Establishments must renew their registration annually, between October 1st and December 31st of each year.
How can FDABasics help with Establishment Registration?
We prepare the establishment registration SPL on behalf of your company and submit to the FDA through our ESG gateway. We also provide US Agent services for non-US companies.
What are the fees for Establishment Registration?
The FDA does not charge any fee for Establishment Registration. See our pricing section for consulting fees.
How long will it take for Establishment Registration?
Generally, it takes two to three working days.
Does the FDA issue Certificates of Registration?
What information is required for Establishment Registration?
The contact address and DUNS number are required for Establishment Registration. Non US-companies are also required to provide US Agent information. If required, we can act as US agent for your company.
Who should register?
As per 21 CFR 207, domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA.
What is the time frame for approval for ANDA Applications?
If all the submitted information is appropriate and correct, the process takes between 12 and 16 months. If you have any other questions about ANDA, please feel to contact us.
How much is ANDA fee?
What information should be included for ANDA?
Generally, ANDA includes chemistry, manufacturing, control, bio study and administrative information.
What is a generic drug?
A generic drug is identical–or bio equivalent–to a brand name drug (already approved by FDA) in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.
Who should file ANDA?
Any companies interested in obtaining generic drug approval should file ANDA.
FDA US Agent
ANDA is the Abbreviated New Drug Application, the FDA’s generic drug approval process.