01 1VENATOR GERMANY GMBH Duisburg DE
01 1Barium sulfate
01 1U.S.A
01 1Valid
Certificate Number : R1-CEP 2006-257 - Rev 04
Status : Valid
Issue Date : 2021-09-29
Type : Chemical
Substance Number : 10
84
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A Radimix Colon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Radimix Colon, including repackagers and relabelers. The FDA regulates Radimix Colon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Radimix Colon API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Radimix Colon supplier is an individual or a company that provides Radimix Colon active pharmaceutical ingredient (API) or Radimix Colon finished formulations upon request. The Radimix Colon suppliers may include Radimix Colon API manufacturers, exporters, distributors and traders.
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A Radimix Colon CEP of the European Pharmacopoeia monograph is often referred to as a Radimix Colon Certificate of Suitability (COS). The purpose of a Radimix Colon CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Radimix Colon EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Radimix Colon to their clients by showing that a Radimix Colon CEP has been issued for it. The manufacturer submits a Radimix Colon CEP (COS) as part of the market authorization procedure, and it takes on the role of a Radimix Colon CEP holder for the record. Additionally, the data presented in the Radimix Colon CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Radimix Colon DMF.
A Radimix Colon CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Radimix Colon CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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