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Status : Withdrawn by Holder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Status : Withdrawn by Holder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Status : Withdrawn by Holder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 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.
click here to find a list of Insulin Bovine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Insulin Bovine CEP of the European Pharmacopoeia monograph is often referred to as a Insulin Bovine Certificate of Suitability (COS). The purpose of a Insulin Bovine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Insulin Bovine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Insulin Bovine to their clients by showing that a Insulin Bovine CEP has been issued for it. The manufacturer submits a Insulin Bovine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Insulin Bovine CEP holder for the record. Additionally, the data presented in the Insulin Bovine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Insulin Bovine DMF.
A Insulin Bovine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Insulin Bovine 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 Insulin Bovine suppliers with CEP (COS) on PharmaCompass.
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