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 : 3865
Submission : 1980-06-19
Status : Inactive
Type : II
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 : 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
A Bovine Insulin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bovine Insulin, including repackagers and relabelers. The FDA regulates Bovine Insulin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bovine Insulin 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 Bovine Insulin supplier is an individual or a company that provides Bovine Insulin active pharmaceutical ingredient (API) or Bovine Insulin finished formulations upon request. The Bovine Insulin suppliers may include Bovine Insulin API manufacturers, exporters, distributors and traders.
click here to find a list of Bovine Insulin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bovine Insulin DMF (Drug Master File) is a document detailing the whole manufacturing process of Bovine Insulin active pharmaceutical ingredient (API) in detail. Different forms of Bovine Insulin DMFs exist exist since differing nations have different regulations, such as Bovine Insulin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bovine Insulin DMF submitted to regulatory agencies in the US is known as a USDMF. Bovine Insulin USDMF includes data on Bovine Insulin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bovine Insulin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bovine Insulin suppliers with USDMF on PharmaCompass.
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