01 1Laboratorios Beta S.A. Buenos Aires AR
02 1N.V. ORGANON Oss NL
03 2Novo Nordisk A/S Bagsvaerd DK
04 1Novo Nordisk Produção Farmacêutica do Brasil Ltda Montes Claros BR
01 3Insulin, bovine
02 1Insulin, bovine, "chromatographed"
03 1Insulin, bovine, "monocomponent"
01 1Argentina
02 1Brazil
03 2Denmark
04 1U.S.A
01 2Valid
02 3Withdrawn by Holder
Certificate Number : R1-CEP 2005-214 - Rev 00
Status : Valid
Issue Date : 2011-01-07
Type : TSE
Substance Number :
Certificate Number : R1-CEP 2000-230 - Rev 00
Status : Valid
Issue Date : 2006-05-17
Type : TSE
Substance Number :
Insulin, Bovine, "monocomponent"
Certificate Number : R0-CEP 2000-135 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2005-03-08
Type : TSE
Substance Number :
Insulin, Bovine, "chromatographed"
Certificate Number : R0-CEP 2000-340 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2005-03-08
Type : TSE
Substance Number :
Certificate Number : R1-CEP 2000-156 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2007-03-06
Type : TSE
Substance Number :
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 CEP of the European Pharmacopoeia monograph is often referred to as a Bovine Insulin Certificate of Suitability (COS). The purpose of a Bovine Insulin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bovine Insulin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bovine Insulin to their clients by showing that a Bovine Insulin CEP has been issued for it. The manufacturer submits a Bovine Insulin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bovine Insulin CEP holder for the record. Additionally, the data presented in the Bovine Insulin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bovine Insulin DMF.
A Bovine Insulin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bovine Insulin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Bovine Insulin suppliers with CEP (COS) on PharmaCompass.
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