01 2Bayer AG
02 1Cipla
03 1Hovione
04 1Merck & Co
05 1Productos Quimicos Naturales
06 1Recordati
01 6DANAZOL
02 1DANAZOL USP
01 2Germany
02 1India
03 1Italy
04 1Mexico
05 1Portugal
06 1U.S.A
01 1Active
02 6Inactive
01 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7584
Submission : 1988-06-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7604
Submission : 1988-06-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5616
Submission : 1984-10-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6287
Submission : 1986-03-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4740
Submission : 1982-10-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24021
Submission : 2010-07-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7971
Submission : 1989-03-08
Status : Inactive
Type : II
A Danazol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Danazol, including repackagers and relabelers. The FDA regulates Danazol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Danazol 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 Danazol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Danazol supplier is an individual or a company that provides Danazol active pharmaceutical ingredient (API) or Danazol finished formulations upon request. The Danazol suppliers may include Danazol API manufacturers, exporters, distributors and traders.
click here to find a list of Danazol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Danazol DMF (Drug Master File) is a document detailing the whole manufacturing process of Danazol active pharmaceutical ingredient (API) in detail. Different forms of Danazol DMFs exist exist since differing nations have different regulations, such as Danazol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Danazol DMF submitted to regulatory agencies in the US is known as a USDMF. Danazol USDMF includes data on Danazol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Danazol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Danazol suppliers with USDMF on PharmaCompass.
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