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Status : Withdrawn by Holder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Status : Withdrawn by Holder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 Insulin Bovine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Insulin Bovine, including repackagers and relabelers. The FDA regulates Insulin Bovine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Insulin Bovine 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 Bovine supplier is an individual or a company that provides Insulin Bovine active pharmaceutical ingredient (API) or Insulin Bovine finished formulations upon request. The Insulin Bovine suppliers may include Insulin Bovine API manufacturers, exporters, distributors and traders.
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