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 3Valid
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 : Valid
Issue Date : 2019-11-26
Type : Chemical
Substance Number : 1117
A Isosorbide Dinitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isosorbide Dinitrate, including repackagers and relabelers. The FDA regulates Isosorbide Dinitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isosorbide Dinitrate 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 Isosorbide Dinitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isosorbide Dinitrate supplier is an individual or a company that provides Isosorbide Dinitrate active pharmaceutical ingredient (API) or Isosorbide Dinitrate finished formulations upon request. The Isosorbide Dinitrate suppliers may include Isosorbide Dinitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Isosorbide Dinitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isosorbide Dinitrate CEP of the European Pharmacopoeia monograph is often referred to as a Isosorbide Dinitrate Certificate of Suitability (COS). The purpose of a Isosorbide Dinitrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Isosorbide Dinitrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Isosorbide Dinitrate to their clients by showing that a Isosorbide Dinitrate CEP has been issued for it. The manufacturer submits a Isosorbide Dinitrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Isosorbide Dinitrate CEP holder for the record. Additionally, the data presented in the Isosorbide Dinitrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Isosorbide Dinitrate DMF.
A Isosorbide Dinitrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Isosorbide Dinitrate 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 Isosorbide Dinitrate suppliers with CEP (COS) on PharmaCompass.
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