01 1Invitrogen Corporation Carlsbad US
02 1LIFE TECHNOLOGIES CORPORATION Carlsbad US
03 1MP BIOMEDICALS NEW ZEALAND LIMITED Auckland NZ
04 1Sigma-Aldrich Corporation Saint Louis US
05 1VASCULAR SOLUTIONS, INC. Minneapolis US
01 1Bovine Thrombin, (New Zealand origin)
02 1Bovine Thrombin, New Zealand origin
03 2Thrombin
04 1Thrombin, Product number T2766
01 1France
02 2India
03 2U.S.A
01 3Valid
02 2Withdrawn by Holder
Bovine Thrombin, (New Zealand Origin)
Certificate Number : R0-CEP 2000-268 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2005-05-13
Type : TSE
Substance Number :
Bovine Thrombin, New Zealand Origin
Certificate Number : CEP 2006-079 - Rev 03
Status : Valid
Issue Date : 2024-10-22
Type : TSE
Substance Number :
Certificate Number : R1-CEP 2008-055 - Rev 00
Status : Valid
Issue Date : 2013-05-17
Type : TSE
Substance Number :
Thrombin, Product Number T2766
Certificate Number : R0-CEP 2000-217 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2006-01-16
Type : TSE
Substance Number :
Certificate Number : R1-CEP 2007-109 - Rev 00
Status : Valid
Issue Date : 2013-02-07
Type : TSE
Substance Number :
A Thrombin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thrombin, including repackagers and relabelers. The FDA regulates Thrombin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thrombin 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 Thrombin supplier is an individual or a company that provides Thrombin active pharmaceutical ingredient (API) or Thrombin finished formulations upon request. The Thrombin suppliers may include Thrombin API manufacturers, exporters, distributors and traders.
click here to find a list of Thrombin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Thrombin CEP of the European Pharmacopoeia monograph is often referred to as a Thrombin Certificate of Suitability (COS). The purpose of a Thrombin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Thrombin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Thrombin to their clients by showing that a Thrombin CEP has been issued for it. The manufacturer submits a Thrombin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Thrombin CEP holder for the record. Additionally, the data presented in the Thrombin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Thrombin DMF.
A Thrombin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Thrombin 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 Thrombin suppliers with CEP (COS) on PharmaCompass.
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