01 2Ashland Industries Europe GmbH Schaffhausen CH
02 1BALAJI AMINES LIMITED Solapur IN
03 1BASF SE Ludwigshafen DE
04 1HUANGSHAN BONSUN PHARMACEUTICALS CO., LTD. Shexian CN
05 1JH NANHANG LIFE SCIENCES CO., LTD. Quzhou CN
06 1STAR-TECH & JRS SPECIALTY PRODUCTS CO., LTD. Chongqing CN
01 2Copovidone, K-value: 25.2-30.8
02 1Copovidone, Nominal K-value 28
03 1Povidone, K-90 and K-90D
04 1Povidone, K17, K25, K30, K90
05 1Povidone, Nominal K-value 30
06 1Povidone, nominal K-value 30
01 3China
02 1Germany
03 1India
04 2Switzerland
01 6Valid
02 1Withdrawn by EDQM Failure to CEP procedure
Copovidone, K-value: 25.2-30.8
Certificate Number : R1-CEP 2010-086 - Rev 00
Status : Valid
Issue Date : 2017-07-07
Type : Chemical
Substance Number : 891
Certificate Number : R1-CEP 2009-142 - Rev 01
Status : Valid
Issue Date : 2017-08-10
Type : Chemical
Substance Number : 685
Certificate Number : R0-CEP 2011-061 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2011-12-19
Type : Chemical
Substance Number : 685
Copovidone, Nominal K-value 28
Certificate Number : R1-CEP 2007-106 - Rev 03
Status : Valid
Issue Date : 2020-09-08
Type : Chemical
Substance Number : 891
Certificate Number : R1-CEP 2014-372 - Rev 00
Status : Valid
Issue Date : 2021-02-05
Type : Chemical
Substance Number : 685
Certificate Number : CEP 2009-020 - Rev 01
Status : Valid
Issue Date : 2024-03-26
Type : Chemical
Substance Number : 685
Copovidone, K-value: 25.2-30.8
Certificate Number : R1-CEP 2014-365 - Rev 00
Status : Valid
Issue Date : 2021-02-16
Type : Chemical
Substance Number : 891
A 1-ethenylpyrrolidin-2-one manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1-ethenylpyrrolidin-2-one, including repackagers and relabelers. The FDA regulates 1-ethenylpyrrolidin-2-one manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1-ethenylpyrrolidin-2-one 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 1-ethenylpyrrolidin-2-one supplier is an individual or a company that provides 1-ethenylpyrrolidin-2-one active pharmaceutical ingredient (API) or 1-ethenylpyrrolidin-2-one finished formulations upon request. The 1-ethenylpyrrolidin-2-one suppliers may include 1-ethenylpyrrolidin-2-one API manufacturers, exporters, distributors and traders.
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A 1-ethenylpyrrolidin-2-one CEP of the European Pharmacopoeia monograph is often referred to as a 1-ethenylpyrrolidin-2-one Certificate of Suitability (COS). The purpose of a 1-ethenylpyrrolidin-2-one CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 1-ethenylpyrrolidin-2-one EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 1-ethenylpyrrolidin-2-one to their clients by showing that a 1-ethenylpyrrolidin-2-one CEP has been issued for it. The manufacturer submits a 1-ethenylpyrrolidin-2-one CEP (COS) as part of the market authorization procedure, and it takes on the role of a 1-ethenylpyrrolidin-2-one CEP holder for the record. Additionally, the data presented in the 1-ethenylpyrrolidin-2-one CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 1-ethenylpyrrolidin-2-one DMF.
A 1-ethenylpyrrolidin-2-one CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 1-ethenylpyrrolidin-2-one 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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