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HomeU.S. FDA Drug RegulationsU.S. FDA Self-Identification Requirements

U.S. FDA Self-Identification Requirements

Operators of facilities that produce generic drugs and generic drug APIs must submit "self-identification" information to FDA between May 1 and June 1 of each year. This information is required by the Generic Drug User Fee Amendments of 2012 (GDUFA), passed by Congress in 2012. FDA uses self-identification data to calculate generic drug user fees. Under GDUFA, if a facility fails to self-identify, the generic drugs it manufacturers will be deemed misbranded.

For assistance with determining whether your firm is subject to FDA's self-identification requirements or submitting self-identification information to FDA, simply complete the fields below. For immediate assistance, click Live Help.

Legal Company Name include corporate designation
(Such as Ltd., SARL, S.A., etc.):
*
Contact Person Name: *
Facility Street Address: *
City: *
State/Province/Region:
Country: *
Postal Code:
Phone: *
Mobile:
Fax:
E-mail: *
FDA Registration Number:
DUNS Number:
Does your firm have any DMF's on file
with the U.S. FDA?
Yes No
Please check all that apply to your facility: *
Our facility is identified or intended to be identified in at least one pending or approved generic drug submission (Abbreviated New Drug Application or ANDA) for a finished dosage form (FDF) of a human generic drug or an active pharmaceutical ingredient (API) contained in a human generic drug;
Our site packages and labels a finished dosage form of a human generic drug into its primary container or closure system;
Our site removes the generic drug from its original primary container or closure system and repackages and relabels it into a different primary container or closure system (contract repackagers);
Our site is a bioequivalence (BE)/bioavailability (BA) testing site that is identified in a generic drug submission and you conduct BE/BA testing, bioanalytical testing of samples collected from clinical BE/BA testing and/or in vitro BE testing;
Our site is identified in a generic drug submission and we perform testing of one or more attributes or characteristics of the final dosage form of the generic drug or the API to satisfy current good manufacturing practice testing requirements (sites that test for research purposes only are excluded).
None of the above functions apply to our facility.
* This information is required. If you need assistance, please click Live Help






 
U.S. FDA Regulations:

Food and Drug Administration Safety and Innovation Act (FDASIA), Generic Drug User Fee Amendments of 2012 (GDUFA)
P.L. 112-144, Title III; 77 F.R. 191, at pp. 60125-26.


































Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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