Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
02 1TAPI Technology & API Services
03 1Gador SA
04 2Gedeon Richter
05 2Industriale Chimica
06 1Lupin Ltd
07 1Merck & Co
08 1Sterling Spa
01 1NORGESTERAL ACETATE OXIME
02 3NORGESTIMATE
03 1NORGESTIMATE BULK DRUG SUBSTANCE
04 3NORGESTIMATE USP
05 1NORGESTIMATE USP (NP)
06 1NORGESTIMATE- DEXNORGESTREL ACETIME
01 1Argentina
02 1France
03 2Hungary
04 1India
05 1Israel
06 3Italy
07 1U.S.A
01 7Active
02 3Inactive
01 3Complete
02 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 : 2364
Submission : 1974-11-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14241
Submission : 1999-06-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16271
Submission : 2002-11-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-02
Pay. Date : 2017-04-18
DMF Number : 19429
Submission : 2006-05-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5708
Submission : 1985-01-21
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-03-11
Pay. Date : 2020-09-28
DMF Number : 33444
Submission : 2019-02-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21518
Submission : 2008-04-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22726
Submission : 2009-04-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19327
Submission : 2006-04-06
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-23
Pay. Date : 2013-04-11
DMF Number : 15649
Submission : 2001-10-04
Status : Active
Type : II
A Norgestimate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Norgestimate, including repackagers and relabelers. The FDA regulates Norgestimate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Norgestimate 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 Norgestimate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Norgestimate supplier is an individual or a company that provides Norgestimate active pharmaceutical ingredient (API) or Norgestimate finished formulations upon request. The Norgestimate suppliers may include Norgestimate API manufacturers, exporters, distributors and traders.
click here to find a list of Norgestimate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Norgestimate DMF (Drug Master File) is a document detailing the whole manufacturing process of Norgestimate active pharmaceutical ingredient (API) in detail. Different forms of Norgestimate DMFs exist exist since differing nations have different regulations, such as Norgestimate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Norgestimate DMF submitted to regulatory agencies in the US is known as a USDMF. Norgestimate USDMF includes data on Norgestimate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Norgestimate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Norgestimate suppliers with USDMF on PharmaCompass.
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