01 4Fujifilm Diosynth Biotechnologies
02 1Laboratorios Beta S.A. AR C1232 AAR Buenos Aires
03 3Novo Nordisk
04 1SAFC
05 1SIGMA TAU
01 1Argentina
02 3Denmark
03 2U.S.A
04 4United Kingdom
01 6Inactive
02 4Blank
01 2Valid
02 2Withdrawn by Holder
03 6Blank
01 10Blank
01 10Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7679
Submission : 1988-09-15
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3865
Submission : 1980-06-19
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3881
Submission : 1980-06-30
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14382
Submission : 1999-09-02
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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 : 21228
Submission : 2008-01-11
Status : Inactive
Type : II
Certificate Number : R1-CEP 2000-230 - Rev 00
Issue Date : 2006-05-17
Type : TSE
Substance Number :
Status : Valid
Certificate Number : R1-CEP 2005-214 - Rev 00
Issue Date : 2011-01-07
Type : TSE
Substance Number :
Status : Valid
Certificate Number : R0-CEP 2000-135 - Rev 02
Issue Date : 2005-03-08
Type : TSE
Substance Number :
Status : Withdrawn by Holder
Certificate Number : R0-CEP 2000-340 - Rev 02
Issue Date : 2005-03-08
Type : TSE
Substance Number :
Status : Withdrawn by Holder
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.
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