01 4Pharmacosmos A/S Holbaek DK
01 1Dextran 1 for injection
02 1Dextran 40 for injection
03 1Dextran 60 for injection
04 1Dextran 70 for injection
01 4Denmark
01 4Valid
Certificate Number : R1-CEP 1999-063 - Rev 03
Status : Valid
Issue Date : 2022-01-03
Type : Chemical
Substance Number : 999
Certificate Number : R1-CEP 1999-064 - Rev 03
Status : Valid
Issue Date : 2022-01-03
Type : Chemical
Substance Number : 1000
Certificate Number : R1-CEP 1999-065 - Rev 03
Status : Valid
Issue Date : 2022-01-03
Type : Chemical
Substance Number : 1001
Certificate Number : R1-CEP 2003-165 - Rev 01
Status : Valid
Issue Date : 2022-01-03
Type : Chemical
Substance Number : 1506
A Dextran 40 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dextran 40, including repackagers and relabelers. The FDA regulates Dextran 40 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dextran 40 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Dextran 40 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dextran 40 supplier is an individual or a company that provides Dextran 40 active pharmaceutical ingredient (API) or Dextran 40 finished formulations upon request. The Dextran 40 suppliers may include Dextran 40 API manufacturers, exporters, distributors and traders.
click here to find a list of Dextran 40 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dextran 40 CEP of the European Pharmacopoeia monograph is often referred to as a Dextran 40 Certificate of Suitability (COS). The purpose of a Dextran 40 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dextran 40 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dextran 40 to their clients by showing that a Dextran 40 CEP has been issued for it. The manufacturer submits a Dextran 40 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dextran 40 CEP holder for the record. Additionally, the data presented in the Dextran 40 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dextran 40 DMF.
A Dextran 40 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dextran 40 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 Dextran 40 suppliers with CEP (COS) on PharmaCompass.
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