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Status : Withdrawn by EDQM Failure to CEP pro...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Status : Withdrawn by Holder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