Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
02 1Bayer AG
03 1Gedeon Richter
04 2Merck & Co
05 1ScinoPharm Taiwan, Ltd
06 1Blank
01 1IDENTIFICATION, ASSAY & SPECIFICATION FOR MESTRANOL
02 5MESTRANOL
03 1MESTRANOL USP
01 1France
02 1Germany
03 1Hungary
04 1Taiwan
05 2U.S.A
06 1Blank
01 7Inactive
01 7Blank
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1614
Submission : 1970-11-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 964
Submission : 1966-05-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5744
Submission : 1985-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3951
Submission : 1980-09-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 901
Submission : 1965-07-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17066
Submission : 2003-12-31
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1174
Submission : 1968-04-24
Status : Inactive
Type : II
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A Mestranol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mestranol, including repackagers and relabelers. The FDA regulates Mestranol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mestranol 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 Mestranol supplier is an individual or a company that provides Mestranol active pharmaceutical ingredient (API) or Mestranol finished formulations upon request. The Mestranol suppliers may include Mestranol API manufacturers, exporters, distributors and traders.
click here to find a list of Mestranol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mestranol DMF (Drug Master File) is a document detailing the whole manufacturing process of Mestranol active pharmaceutical ingredient (API) in detail. Different forms of Mestranol DMFs exist exist since differing nations have different regulations, such as Mestranol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mestranol DMF submitted to regulatory agencies in the US is known as a USDMF. Mestranol USDMF includes data on Mestranol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mestranol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mestranol suppliers with USDMF on PharmaCompass.
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