Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
02 4Biocon
03 2Novo Nordisk
01 1HUMAN INSULIN (SEMI-SYNTHETIC) AS PROCESSED IN KALUNDBORG & BAGSVAERD
02 1HUMAN INSULIN DRUG SUBSTANCE (rDNA ORIGIN)
03 1HUMAN INSULIN INJ NEUTRAL 500 UNITS/ML PREPARED & PKG BAGSVAERD PLANT
04 1HUMAN INSULIN-BULK (RDNA ORIGIN)
05 1HUMAN INSULIN-BULK (RDNA ORIGIN) (ANIMAL ORIGIN FREE)
06 1HUMAN INSULIN-BULK (rDNA ORIGIN) - (ANIMAL ORIGIN FREE)
07 1HUMAN INSULIN-SEMISYNTHETIC, BULK MATRLS & FINISHED DOS. FORM
01 2Denmark
02 1France
03 4India
01 1Active
02 6Inactive
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 : 4846
Submission : 1983-03-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23892
Submission : 2010-06-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17123
Submission : 2004-01-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32125
Submission : 2017-12-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27702
Submission : 2013-11-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5533
Submission : 1984-09-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5527
Submission : 1984-09-14
Status : Inactive
Type : II
36
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A LY275585 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of LY275585, including repackagers and relabelers. The FDA regulates LY275585 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. LY275585 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A LY275585 DMF (Drug Master File) is a document detailing the whole manufacturing process of LY275585 active pharmaceutical ingredient (API) in detail. Different forms of LY275585 DMFs exist exist since differing nations have different regulations, such as LY275585 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A LY275585 DMF submitted to regulatory agencies in the US is known as a USDMF. LY275585 USDMF includes data on LY275585's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The LY275585 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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