01 4Fujifilm Diosynth Biotechnologies
02 1SAFC
03 1SIGMA TAU
01 1BOVINE INSULIN
02 2BOVINE INSULIN HIGHLY PURIFIED
03 1BOVINE INSULINE HIGHLY PURIFIED
04 1INSULIN FROM BOVINE PANCREAS
05 1TrypZean Bovine, Recombinant Expressed in Corn
01 2U.S.A
02 4United Kingdom
01 6Inactive
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14833
Submission : 2000-04-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14382
Submission : 1999-09-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3881
Submission : 1980-06-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3865
Submission : 1980-06-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21228
Submission : 2008-01-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7679
Submission : 1988-09-15
Status : Inactive
Type : II
16
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A INSULIN RECOMBINANT HUMAN manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of INSULIN RECOMBINANT HUMAN, including repackagers and relabelers. The FDA regulates INSULIN RECOMBINANT HUMAN manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. INSULIN RECOMBINANT HUMAN 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 INSULIN RECOMBINANT HUMAN supplier is an individual or a company that provides INSULIN RECOMBINANT HUMAN active pharmaceutical ingredient (API) or INSULIN RECOMBINANT HUMAN finished formulations upon request. The INSULIN RECOMBINANT HUMAN suppliers may include INSULIN RECOMBINANT HUMAN API manufacturers, exporters, distributors and traders.
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A INSULIN RECOMBINANT HUMAN DMF (Drug Master File) is a document detailing the whole manufacturing process of INSULIN RECOMBINANT HUMAN active pharmaceutical ingredient (API) in detail. Different forms of INSULIN RECOMBINANT HUMAN DMFs exist exist since differing nations have different regulations, such as INSULIN RECOMBINANT HUMAN USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A INSULIN RECOMBINANT HUMAN DMF submitted to regulatory agencies in the US is known as a USDMF. INSULIN RECOMBINANT HUMAN USDMF includes data on INSULIN RECOMBINANT HUMAN's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The INSULIN RECOMBINANT HUMAN USDMF is kept confidential to protect the manufacturer’s intellectual property.
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