01 2DIPHARMA FRANCIS S.R.L. Baranzate IT
02 1EIRCHEM PHARMA SERVICES LIMITED Shannon IE
01 1Isosorbide dinitrate, diluted
02 1Isosorbide dinitrate, diluted, 25% in lactose monohydrate
03 1Isosorbide dinitrate, diluted, 40% in lactose monohydrate
01 1Ireland
02 2Italy
01 2Valid
02 1Withdrawn by EDQM Failure to CEP procedure
Isosorbide Dinitrate, Diluted, 25% In Lactose Mo...
Certificate Number : R1-CEP 2013-295 - Rev 00
Status : Valid
Issue Date : 2022-02-09
Type : Chemical
Substance Number : 1117
Isosorbide Dinitrate, Diluted, 40% In Lactose Mo...
Certificate Number : R1-CEP 2013-298 - Rev 00
Status : Valid
Issue Date : 2022-02-09
Type : Chemical
Substance Number : 1117
Certificate Number : R1-CEP 1998-133 - Rev 05
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2019-11-26
Type : Chemical
Substance Number : 1117
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A Isoket Retard 120 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isoket Retard 120, including repackagers and relabelers. The FDA regulates Isoket Retard 120 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isoket Retard 120 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 Isoket Retard 120 supplier is an individual or a company that provides Isoket Retard 120 active pharmaceutical ingredient (API) or Isoket Retard 120 finished formulations upon request. The Isoket Retard 120 suppliers may include Isoket Retard 120 API manufacturers, exporters, distributors and traders.
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A Isoket Retard 120 CEP of the European Pharmacopoeia monograph is often referred to as a Isoket Retard 120 Certificate of Suitability (COS). The purpose of a Isoket Retard 120 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Isoket Retard 120 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Isoket Retard 120 to their clients by showing that a Isoket Retard 120 CEP has been issued for it. The manufacturer submits a Isoket Retard 120 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Isoket Retard 120 CEP holder for the record. Additionally, the data presented in the Isoket Retard 120 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Isoket Retard 120 DMF.
A Isoket Retard 120 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Isoket Retard 120 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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