01 1Choongwae Pharma Corporation Seoul
02 1DERIVADOS QUIMICOS, S.A.U. Alcantarilla ES
03 1JANSSEN PHARMACEUTICA NV Beerse BE
04 1Janssen Pharmaceutical Ltd County Cork IE
05 1PIRAMAL PHARMA LIMITED Digwal Village IN
06 1Uquifa Mexico S.A. de C.V. Jiutepec MX
01 6Ketoconazole
01 1Belgium
02 1South Korea
03 2Spain
04 2U.S.A
01 1Expired
02 4Valid
03 1Withdrawn by Holder
Certificate Number : R0-CEP 2000-287 - Rev 02
Status : Expired
Issue Date : 2004-10-20
Type : Chemical
Substance Number : 921
Certificate Number : CEP 2016-102 - Rev 03
Status : Valid
Issue Date : 2023-10-23
Type : Chemical
Substance Number : 921
Certificate Number : R2-CEP 1995-009 - Rev 04
Status : Valid
Issue Date : 2021-03-08
Type : Chemical
Substance Number : 921
Certificate Number : R0-CEP 1997-105 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2003-08-20
Type : Chemical
Substance Number : 921
Certificate Number : R1-CEP 1999-049 - Rev 10
Status : Valid
Issue Date : 2022-01-07
Type : Chemical
Substance Number : 921
Certificate Number : R1-CEP 2005-138 - Rev 04
Status : Valid
Issue Date : 2021-04-21
Type : Chemical
Substance Number : 921
A Ketoconazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ketoconazole, including repackagers and relabelers. The FDA regulates Ketoconazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ketoconazole API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Ketoconazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ketoconazole supplier is an individual or a company that provides Ketoconazole active pharmaceutical ingredient (API) or Ketoconazole finished formulations upon request. The Ketoconazole suppliers may include Ketoconazole API manufacturers, exporters, distributors and traders.
click here to find a list of Ketoconazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ketoconazole CEP of the European Pharmacopoeia monograph is often referred to as a Ketoconazole Certificate of Suitability (COS). The purpose of a Ketoconazole CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ketoconazole EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ketoconazole to their clients by showing that a Ketoconazole CEP has been issued for it. The manufacturer submits a Ketoconazole CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ketoconazole CEP holder for the record. Additionally, the data presented in the Ketoconazole CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ketoconazole DMF.
A Ketoconazole CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ketoconazole 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 Ketoconazole suppliers with CEP (COS) on PharmaCompass.
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