01 1Ajinomoto Company
02 1Catalent Pharma Solutions
03 1Chemi SpA
04 1Corden Pharma Bergamo S.p.A
05 1Erregierre SpA
06 1FDC
07 1Gufic Biosciences
08 1Johnson & Johnson Innovative Medicine
09 1Quimica Sintetica
10 1Sifavitor srl
11 1YUNG ZIP CHEMICAL INDUSTRIAL
12 5Blank
01 11MICONAZOLE NITRATE
02 1MICONAZOLE NITRATE & BASE
03 1MICONAZOLE NITRATE (1,200MG) VAGINAL OVULE SOFT-GELATIN CAPSULE
04 1MICONAZOLE NITRATE DRUG SUBSTANCE
05 2MICONAZOLE NITRATE USP
01 2India
02 4Italy
03 1Japan
04 1Spain
05 1Taiwan
06 2U.S.A
07 5Blank
01 6Active
02 10Inactive
01 3Complete
02 13Blank
GDUFA
DMF Review : Complete
Rev. Date : 2015-03-16
Pay. Date : 2014-02-14
DMF Number : 27904
Submission : 2014-02-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6870
Submission : 1987-03-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-31
Pay. Date : 2023-03-29
DMF Number : 7376
Submission : 1988-03-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8205
Submission : 1989-09-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-05
Pay. Date : 2015-09-28
DMF Number : 10518
Submission : 1993-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6982
Submission : 1987-05-27
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8471
Submission : 1990-03-21
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 : 8095
Submission : 1989-06-07
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 : 6882
Submission : 1987-03-16
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 : 4653
Submission : 1982-09-13
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Brentan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Brentan, including repackagers and relabelers. The FDA regulates Brentan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Brentan 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 Brentan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Brentan supplier is an individual or a company that provides Brentan active pharmaceutical ingredient (API) or Brentan finished formulations upon request. The Brentan suppliers may include Brentan API manufacturers, exporters, distributors and traders.
click here to find a list of Brentan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Brentan DMF (Drug Master File) is a document detailing the whole manufacturing process of Brentan active pharmaceutical ingredient (API) in detail. Different forms of Brentan DMFs exist exist since differing nations have different regulations, such as Brentan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Brentan DMF submitted to regulatory agencies in the US is known as a USDMF. Brentan USDMF includes data on Brentan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Brentan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Brentan suppliers with USDMF on PharmaCompass.
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