Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
02 1Gador SA
03 2Gedeon Richter
04 1Sterling Spa
01 217-DEACETYL NORGESTIMATE
02 117-DEACETYLNORGESTIMATE (NORELGESTROMIN)
03 1NORELGESTROMIN
04 1NORELGESTROMIN USP
01 1Argentina
02 1France
03 2Hungary
04 1Italy
01 3Active
02 2Inactive
01 3Complete
02 2Blank
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 : 17115
Submission : 2004-01-23
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-02-05
Pay. Date : 2019-06-11
DMF Number : 20004
Submission : 2006-11-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-12
Pay. Date : 2019-04-29
DMF Number : 16404
Submission : 2003-02-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13025
Submission : 1998-06-17
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-07-19
Pay. Date : 2017-10-19
DMF Number : 18125
Submission : 2005-02-28
Status : Active
Type : II
A Norelgestromin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Norelgestromin, including repackagers and relabelers. The FDA regulates Norelgestromin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Norelgestromin 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 Norelgestromin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Norelgestromin supplier is an individual or a company that provides Norelgestromin active pharmaceutical ingredient (API) or Norelgestromin finished formulations upon request. The Norelgestromin suppliers may include Norelgestromin API manufacturers, exporters, distributors and traders.
click here to find a list of Norelgestromin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Norelgestromin DMF (Drug Master File) is a document detailing the whole manufacturing process of Norelgestromin active pharmaceutical ingredient (API) in detail. Different forms of Norelgestromin DMFs exist exist since differing nations have different regulations, such as Norelgestromin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Norelgestromin DMF submitted to regulatory agencies in the US is known as a USDMF. Norelgestromin USDMF includes data on Norelgestromin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Norelgestromin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Norelgestromin suppliers with USDMF on PharmaCompass.
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