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Status : Withdrawn by EDQM Failure to CEP pro...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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PharmaCompass offers a list of Isosorbide Dinitrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Isosorbide Dinitrate manufacturer or Isosorbide Dinitrate supplier for your needs.
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PharmaCompass also assists you with knowing the Isosorbide Dinitrate API Price utilized in the formulation of products. Isosorbide Dinitrate API Price is not always fixed or binding as the Isosorbide Dinitrate Price is obtained through a variety of data sources. The Isosorbide Dinitrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Isoket manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isoket, including repackagers and relabelers. The FDA regulates Isoket manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isoket 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 supplier is an individual or a company that provides Isoket active pharmaceutical ingredient (API) or Isoket finished formulations upon request. The Isoket suppliers may include Isoket API manufacturers, exporters, distributors and traders.
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A Isoket CEP of the European Pharmacopoeia monograph is often referred to as a Isoket Certificate of Suitability (COS). The purpose of a Isoket CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Isoket EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Isoket to their clients by showing that a Isoket CEP has been issued for it. The manufacturer submits a Isoket CEP (COS) as part of the market authorization procedure, and it takes on the role of a Isoket CEP holder for the record. Additionally, the data presented in the Isoket CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Isoket DMF.
A Isoket CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Isoket 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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