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GDUFA Self Identification


Establishment Details
Registrant is owner of the facility, this is applicable when your actual manufacturing facility is group of company.if not applicable leave blank.
Provide 9 digit DUNS number, if you don't have DUNS number please contact us we will help you to get the DUNS number
Street Address
Address Line 2
City
State/Region/Province
Provide street address, if postal code is not applicable then mention as NONE

If not applicable mention as 0000
country code-area code-telephone :ext
Email
Add Establishment
Establishment is the actual manufacturing location which need to registered, there should be at least one establishment
Name of the facility which is involved in generic drug application
Please enter 9 digit DUNS number
If FEI number does not exists we will assist to get this FEI number.
Street Address
Address Line 2
City
State/Region/Province
Postal / Zip Code, if not applicable mention NA
Country
Enter street address

First Name
Last Name
Is Contact person address different from establishment address

ANALYSIS
API/FDF ANALYTICAL TESTING C
API MANUFACTURE
CLINICAL BIOEQUIVALENCE OR BIOAVAILABILITY
FINISHED DRUG MANUFACTURER
IN VITRO BIOEQUIVALENCE OR BIOANALYTICAL TESTING
PACK
POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION
REPACK

Add additional establishment 2 (OPTIONAL)


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