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Drug Establishment Registration


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
If not applicable mention as NA
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
Enter 9 digit DUNS number, if DUNS number not available please contact us we will help you to get the DUNS number
Street Address
Address Line 2
City
State/Region/Province
Postal / Zip Code, if not applicable mention NA
Country
First Name
Last Name
Is contact person address different from establishment address

ANALYSIS
API/FDF ANALYTICAL TESTING C
API MANUFACTURE
CLINICAL BIOEQUIVALENCE OR BIOAVAILABILITY STUDY
DISTRIBUTES DRUG PRODUCTS UNDER OWN PRIVATE LABEL
FDF MANUFACTURE
HUMAN DRUG COMPOUNDING OUTSOURCING FACILITY
IMPORT
IN VITRO BIOEQUIVALENCE OR BIOANALYTICAL TESTING
LABEL
MANUFACTURE
MEDICATED ANIMAL FEED MANUFACTURE
OUTSOURCING ANIMAL DRUG COMPOUNDING
PACK
PARTICLE SIZE REDUCTION
POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION
RELABEL
REPACK
SALVAGE
STERILIZE
THIRD-PARTY LOGISTICS PROVIDER
TRANSFILL UNITED STATES AGENT
WHOLESALE DRUG DISTRIBUTOR
Check all operations your perform

First Choice
Second Choice
Third Choice
Compounding from bulk ingredient
Compounding sterile products
Distributes human prescription drug products
Distributes human over-the-counter drug products
Intent to compound 506E (drug shortage) drugs
Manufactures animal prescription drug products
Manufactures animal over-the-counter drug products
Manufactures animal over-the-counter Type A medicated article drug products
Manufactures human over-the-counter drug products
Manufactures human prescription drug products
Manufactures Non-Generics
Manufactures veterinary feed directive Type A medicated article drug products
No intent to compound 506E (drug shortage) drugs
Not compounding from bulk ingredient
Not compounding sterile products
Transfills Medical Gas
Warehouses human prescription drug products
Please choose applicable business qualifier

Add additional establishment 2

Upload product brochure and catalog if any.
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