01 2Catalent Pharma Solutions
02 1Chemi SpA
03 1Corden Pharma Bergamo S.p.A
04 1Erregierre SpA
05 1F. Hoffmann-La Roche
06 1FDC
07 1Johnson & Johnson Innovative Medicine
08 1Sifavitor srl
09 2YUNG ZIP CHEMICAL INDUSTRIAL
01 2MICONAZOLE
02 1MICONAZOLE 1200 MG SOFTGELS
03 4MICONAZOLE BASE
04 1MICONAZOLE DRUG SUBSTANCE
05 1MICONAZOLE GELATIN ENCAPSULATED VAGINAL SUPPOSITORY 200 MG
06 1MICONAZOLE USP
07 1MICONAZOLE VAGINAL CREAM
01 1India
02 4Italy
03 1Switzerland
04 2Taiwan
05 3U.S.A
01 2Active
02 9Inactive
01 11Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19943
Submission : 2006-11-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20627
Submission : 2007-06-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9648
Submission : 1992-04-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18248
Submission : 2005-04-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7040
Submission : 1987-06-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10579
Submission : 1993-11-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10912
Submission : 1994-05-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17871
Submission : 2004-12-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30988
Submission : 2016-08-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15110
Submission : 2000-10-25
Status : Inactive
Type : II
A Miconazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Miconazole, including repackagers and relabelers. The FDA regulates Miconazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Miconazole 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 Miconazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Miconazole supplier is an individual or a company that provides Miconazole active pharmaceutical ingredient (API) or Miconazole finished formulations upon request. The Miconazole suppliers may include Miconazole API manufacturers, exporters, distributors and traders.
click here to find a list of Miconazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Miconazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Miconazole active pharmaceutical ingredient (API) in detail. Different forms of Miconazole DMFs exist exist since differing nations have different regulations, such as Miconazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Miconazole DMF submitted to regulatory agencies in the US is known as a USDMF. Miconazole USDMF includes data on Miconazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Miconazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Miconazole suppliers with USDMF on PharmaCompass.
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