01 1Cerestar USA Inc Hammond US
01 1Betadex
01 1U.S.A
01 1Expired
Certificate Number : R0-CEP 2002-130 - Rev 00
Status : Expired
Issue Date : 2006-06-21
Type : Chemical
Substance Number : 1070
A Betadex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betadex, including repackagers and relabelers. The FDA regulates Betadex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betadex 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 Betadex supplier is an individual or a company that provides Betadex active pharmaceutical ingredient (API) or Betadex finished formulations upon request. The Betadex suppliers may include Betadex API manufacturers, exporters, distributors and traders.
click here to find a list of Betadex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Betadex CEP of the European Pharmacopoeia monograph is often referred to as a Betadex Certificate of Suitability (COS). The purpose of a Betadex CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Betadex EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Betadex to their clients by showing that a Betadex CEP has been issued for it. The manufacturer submits a Betadex CEP (COS) as part of the market authorization procedure, and it takes on the role of a Betadex CEP holder for the record. Additionally, the data presented in the Betadex CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Betadex DMF.
A Betadex CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Betadex 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 Betadex suppliers with CEP (COS) on PharmaCompass.
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