01 1Cardinal Health
02 1Cooper Surgical
03 1Dupont
04 1EASTMAN KODAK
05 1Hamari chemicals
06 1NuView Life Sciences
07 1SAFC
08 2Blank
01 1(ETHYLENEDINITRILO) TETRAACETIC ACID COPPER DISODIUM SALT
02 1COPPER (II) CHLORIDE DIHYDRATE
03 1COPPER CHLORIDE CU-67 RADIOCHEMICAL
04 1COPPER GLYCINATE MONOHYDRATE
05 1COPPER T MODEL TCU 380A INTRAUTERINE CONTRACEPTIVE
06 1COPPER-64 (NITRATE & CHLORIDE)
07 2GLY-HIS-LYS TRIPEPTIDE COPPER CHELATE
08 1TETRAKIS (2-METHOXYISOBUTYLISONITRILE) COPPER (I) TETRAFLUOROBORATE DRUG SUBSTANCE
01 1Japan
02 6U.S.A
03 2Blank
01 2Active
02 7Inactive
01 9Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20079
Submission : 2006-12-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8298
Submission : 1989-11-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2526
Submission : 1975-08-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7555
Submission : 1988-06-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9615
Submission : 1990-10-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19791
Submission : 2006-09-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9417
Submission : 1991-11-15
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11177
Submission : 1994-10-31
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9613
Submission : 1991-05-15
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Copper manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Copper, including repackagers and relabelers. The FDA regulates Copper manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Copper 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 Copper supplier is an individual or a company that provides Copper active pharmaceutical ingredient (API) or Copper finished formulations upon request. The Copper suppliers may include Copper API manufacturers, exporters, distributors and traders.
click here to find a list of Copper suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Copper DMF (Drug Master File) is a document detailing the whole manufacturing process of Copper active pharmaceutical ingredient (API) in detail. Different forms of Copper DMFs exist exist since differing nations have different regulations, such as Copper USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Copper DMF submitted to regulatory agencies in the US is known as a USDMF. Copper USDMF includes data on Copper's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Copper USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Copper suppliers with USDMF on PharmaCompass.
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