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 : 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 : 17123
Submission : 2004-01-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5527
Submission : 1984-09-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5533
Submission : 1984-09-14
Status : Inactive
Type : II
A Humalog manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Humalog, including repackagers and relabelers. The FDA regulates Humalog manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Humalog 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 Humalog manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Humalog supplier is an individual or a company that provides Humalog active pharmaceutical ingredient (API) or Humalog finished formulations upon request. The Humalog suppliers may include Humalog API manufacturers, exporters, distributors and traders.
click here to find a list of Humalog suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Humalog DMF (Drug Master File) is a document detailing the whole manufacturing process of Humalog active pharmaceutical ingredient (API) in detail. Different forms of Humalog DMFs exist exist since differing nations have different regulations, such as Humalog USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Humalog DMF submitted to regulatory agencies in the US is known as a USDMF. Humalog USDMF includes data on Humalog's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Humalog USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Humalog suppliers with USDMF on PharmaCompass.
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