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