Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
01 1CURIA FRANCE S.A.S. Bon-Encontre FR
02 1Dishman Pharmaceuticals and Chemicals Limited Ahmedabad IN
01 2Hexetidine
01 1India
02 1U.S.A
01 1Valid
02 1Withdrawn by Holder
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
Certificate Number : R1-CEP 2005-238 - Rev 03
Status : Valid
Issue Date : 2022-08-25
Type : Chemical
Substance Number : 1221
Certificate Number : R0-CEP 2010-238 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2012-09-10
Type : Chemical
Substance Number : 1221
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A Duranil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Duranil, including repackagers and relabelers. The FDA regulates Duranil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Duranil 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 Duranil supplier is an individual or a company that provides Duranil active pharmaceutical ingredient (API) or Duranil finished formulations upon request. The Duranil suppliers may include Duranil API manufacturers, exporters, distributors and traders.
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A Duranil CEP of the European Pharmacopoeia monograph is often referred to as a Duranil Certificate of Suitability (COS). The purpose of a Duranil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Duranil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Duranil to their clients by showing that a Duranil CEP has been issued for it. The manufacturer submits a Duranil CEP (COS) as part of the market authorization procedure, and it takes on the role of a Duranil CEP holder for the record. Additionally, the data presented in the Duranil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Duranil DMF.
A Duranil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Duranil 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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