01 1Actylis
02 2Amcol
03 1Dolder AG
04 1Nantong Jinghua Pharmaceutical
05 1Teva Pharmaceutical Industries
06 8Blank
01 15-FLUORO-URACIL,PRODUCT 4965
02 55-FLUOROURACIL
03 4FLUOROURACIL
04 1FLUOROURACIL IN MICROSPONGE® POLYMER (FLUROURACIL IN METHYL METHACRYLATE/DIMETHACRYLATE CROSSPOLYMER)
05 1FLUOROURACIL USP
06 1POLY-PORE® FLUOROURACIL POLYMER
07 1STERILE PROCESSING FACILITY IN NEW MEXICO
01 1China
02 1Israel
03 1Switzerland
04 3U.S.A
05 8Blank
01 5Active
02 9Inactive
01 4Complete
02 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4959
Submission : 1983-05-18
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-07
Pay. Date : 2015-07-08
DMF Number : 29443
Submission : 2015-11-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12738
Submission : 1997-11-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-16
Pay. Date : 2014-05-20
DMF Number : 21774
Submission : 2008-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-05-06
Pay. Date : 2020-04-29
DMF Number : 18478
Submission : 2005-06-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-30
Pay. Date : 2012-11-08
DMF Number : 3062
Submission : 1977-11-09
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6098
Submission : 1985-10-23
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 : 2892
Submission : 1977-03-08
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 : 1138
Submission : 1968-02-02
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 : 7179
Submission : 1987-10-08
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A 5 Fluorouracil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 5 Fluorouracil, including repackagers and relabelers. The FDA regulates 5 Fluorouracil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 5 Fluorouracil API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of 5 Fluorouracil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 5 Fluorouracil supplier is an individual or a company that provides 5 Fluorouracil active pharmaceutical ingredient (API) or 5 Fluorouracil finished formulations upon request. The 5 Fluorouracil suppliers may include 5 Fluorouracil API manufacturers, exporters, distributors and traders.
click here to find a list of 5 Fluorouracil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 5 Fluorouracil DMF (Drug Master File) is a document detailing the whole manufacturing process of 5 Fluorouracil active pharmaceutical ingredient (API) in detail. Different forms of 5 Fluorouracil DMFs exist exist since differing nations have different regulations, such as 5 Fluorouracil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 5 Fluorouracil DMF submitted to regulatory agencies in the US is known as a USDMF. 5 Fluorouracil USDMF includes data on 5 Fluorouracil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 5 Fluorouracil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 5 Fluorouracil suppliers with USDMF on PharmaCompass.
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