01 1EDMOND PHARMA S.R.L. Paderno Dugnano IT
01 1Terfenadine
01 1Italy
01 1Expired
Certificate Number : R1-CEP 1997-010 - Rev 01
Status : Expired
Issue Date : 2004-10-28
Type : Chemical
Substance Number : 955
10
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A .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol, including repackagers and relabelers. The FDA regulates .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol 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 .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol supplier is an individual or a company that provides .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol active pharmaceutical ingredient (API) or .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol finished formulations upon request. The .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol suppliers may include .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol API manufacturers, exporters, distributors and traders.
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A .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol CEP of the European Pharmacopoeia monograph is often referred to as a .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol Certificate of Suitability (COS). The purpose of a .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol to their clients by showing that a .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol CEP has been issued for it. The manufacturer submits a .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol CEP (COS) as part of the market authorization procedure, and it takes on the role of a .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol CEP holder for the record. Additionally, the data presented in the .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol DMF.
A .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. .alpha.-(4-(1,1-dimethylethyl)phenyl)-4-(hydroxydiphenyl-methyl)-1-piperidine butanol 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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