01 1CSPC INNOVATION PHARMACEUTICAL CO., LTD. Shijiazhuang City CN
02 1Jilin Shulan Synthetic Pharmaceutical Co. Ltd. Shulan City CN
03 2SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH Minden DE
01 3Theophylline-ethylenediamine
02 1Theophylline-ethylenediamine hydrate
01 2China
02 2Switzerland
01 2Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 1Withdrawn by Holder
Certificate Number : R0-CEP 2007-345 - Rev 01
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2010-02-09
Type : Chemical
Substance Number : 300
Certificate Number : R1-CEP 2004-140 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2011-09-19
Type : Chemical
Substance Number : 300
Certificate Number : R1-CEP 2007-288 - Rev 01
Status : Valid
Issue Date : 2015-12-15
Type : Chemical
Substance Number : 300
Theophylline-ethylenediamine Hydrate
Certificate Number : R1-CEP 2007-289 - Rev 01
Status : Valid
Issue Date : 2015-12-15
Type : Chemical
Substance Number : 301
45
PharmaCompass offers a list of Aminophylline 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 Aminophylline manufacturer or Aminophylline supplier for your needs.
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A Theo Dur manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Theo Dur, including repackagers and relabelers. The FDA regulates Theo Dur manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Theo Dur 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 Theo Dur supplier is an individual or a company that provides Theo Dur active pharmaceutical ingredient (API) or Theo Dur finished formulations upon request. The Theo Dur suppliers may include Theo Dur API manufacturers, exporters, distributors and traders.
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A Theo Dur CEP of the European Pharmacopoeia monograph is often referred to as a Theo Dur Certificate of Suitability (COS). The purpose of a Theo Dur CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Theo Dur EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Theo Dur to their clients by showing that a Theo Dur CEP has been issued for it. The manufacturer submits a Theo Dur CEP (COS) as part of the market authorization procedure, and it takes on the role of a Theo Dur CEP holder for the record. Additionally, the data presented in the Theo Dur CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Theo Dur DMF.
A Theo Dur CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Theo Dur 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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