01 1Erregierre S.p.A. San Paolo D'Argon IT
02 1JANSSEN PHARMACEUTICA NV Beerse BE
01 1Isoconazole nitrate
02 1Isoconazole nitrate, Standard and micronised
01 1Belgium
02 1Italy
01 1Valid
02 1Withdrawn by Holder
Isoconazole Nitrate, Standard And Micronised
Certificate Number : CEP 2014-282 - Rev 01
Status : Valid
Issue Date : 2023-10-18
Type : Chemical
Substance Number : 1017
Certificate Number : R1-CEP 1999-080 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2010-07-20
Type : Chemical
Substance Number : 1017
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A Adestan G 100; Fazol; Gyno-Travogen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Adestan G 100; Fazol; Gyno-Travogen, including repackagers and relabelers. The FDA regulates Adestan G 100; Fazol; Gyno-Travogen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Adestan G 100; Fazol; Gyno-Travogen 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 Adestan G 100; Fazol; Gyno-Travogen supplier is an individual or a company that provides Adestan G 100; Fazol; Gyno-Travogen active pharmaceutical ingredient (API) or Adestan G 100; Fazol; Gyno-Travogen finished formulations upon request. The Adestan G 100; Fazol; Gyno-Travogen suppliers may include Adestan G 100; Fazol; Gyno-Travogen API manufacturers, exporters, distributors and traders.
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A Adestan G 100; Fazol; Gyno-Travogen CEP of the European Pharmacopoeia monograph is often referred to as a Adestan G 100; Fazol; Gyno-Travogen Certificate of Suitability (COS). The purpose of a Adestan G 100; Fazol; Gyno-Travogen CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Adestan G 100; Fazol; Gyno-Travogen EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Adestan G 100; Fazol; Gyno-Travogen to their clients by showing that a Adestan G 100; Fazol; Gyno-Travogen CEP has been issued for it. The manufacturer submits a Adestan G 100; Fazol; Gyno-Travogen CEP (COS) as part of the market authorization procedure, and it takes on the role of a Adestan G 100; Fazol; Gyno-Travogen CEP holder for the record. Additionally, the data presented in the Adestan G 100; Fazol; Gyno-Travogen CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Adestan G 100; Fazol; Gyno-Travogen DMF.
A Adestan G 100; Fazol; Gyno-Travogen CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Adestan G 100; Fazol; Gyno-Travogen 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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