01 1Becton, Dickinson and Company Sparks US
02 1NEW ZEALAND PHARMACEUTICALS LTD. Palmerston North NZ
01 1Bile Acids and Derivatives, Cholic acid, Deoxycholic acid, Dehydrocholic acid, Mixed bile acids, Sodium cholate, Sodium deoxycholate, Bile salts N°3 and Sodium taurocholate
02 1Bile Salts, Product codes: 213010 and 213020
01 1New Zealand
02 1U.S.A
01 2Valid
Bile Salts, Product Codes: 213010 And 213020
Certificate Number : R1-CEP 2001-027 - Rev 00
Status : Valid
Issue Date : 2007-07-18
Type : TSE
Substance Number :
Bile Acids And Derivatives, Cholic Acid, Deoxych...
Certificate Number : CEP 2000-383 - Rev 06
Status : Valid
Issue Date : 2024-05-30
Type : TSE
Substance Number :
A Bile Salts manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bile Salts, including repackagers and relabelers. The FDA regulates Bile Salts manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bile Salts 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 Bile Salts supplier is an individual or a company that provides Bile Salts active pharmaceutical ingredient (API) or Bile Salts finished formulations upon request. The Bile Salts suppliers may include Bile Salts API manufacturers, exporters, distributors and traders.
click here to find a list of Bile Salts suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bile Salts CEP of the European Pharmacopoeia monograph is often referred to as a Bile Salts Certificate of Suitability (COS). The purpose of a Bile Salts CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bile Salts EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bile Salts to their clients by showing that a Bile Salts CEP has been issued for it. The manufacturer submits a Bile Salts CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bile Salts CEP holder for the record. Additionally, the data presented in the Bile Salts CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bile Salts DMF.
A Bile Salts CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bile Salts 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 Bile Salts suppliers with CEP (COS) on PharmaCompass.
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