01 3ABX Advanced Biochemical Compounds
02 1DMFs Not Supported
03 1Eckert & Ziegler Strahlen
04 1GE Healthcare Inc
05 1IRE Elit
06 1Isotope Technologies Munich
01 168 GA GALLIUM CHLORIDE
02 168GE/68GA GENERATOR
03 168GE/68GA-GENERATOR
04 1CASSETTE FOR SYNTHESIS OF 68 GA PEPTIDES
05 1GALLIUM (GA 67) EMERYVILLE,CA; SOUTH PLAINFIELD,NJ; NORTH ARLINGTON,IL
06 1GALLIUM 68 RADIONUCLIDE GENERATOR
07 1PSMA-11
08 1REAGENT KIT FOR SYNTHESIS OF 68GA PEPTIDES USING CATIONIC PURIFICATION
01 1Belgium
02 5Germany
03 1United Kingdom
04 1Blank
01 5Active
02 3Inactive
01 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33682
Submission : 2019-04-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36826
Submission : 2022-03-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36825
Submission : 2022-03-04
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33795
Submission : 2019-09-19
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28741
Submission : 2014-10-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3752
Submission : 1980-03-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31715
Submission : 2017-03-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34938
Submission : 2020-07-10
Status : Active
Type : II
A Gallium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gallium, including repackagers and relabelers. The FDA regulates Gallium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gallium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Gallium supplier is an individual or a company that provides Gallium active pharmaceutical ingredient (API) or Gallium finished formulations upon request. The Gallium suppliers may include Gallium API manufacturers, exporters, distributors and traders.
click here to find a list of Gallium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gallium DMF (Drug Master File) is a document detailing the whole manufacturing process of Gallium active pharmaceutical ingredient (API) in detail. Different forms of Gallium DMFs exist exist since differing nations have different regulations, such as Gallium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gallium DMF submitted to regulatory agencies in the US is known as a USDMF. Gallium USDMF includes data on Gallium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gallium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gallium suppliers with USDMF on PharmaCompass.
We have 5 companies offering Gallium
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
