01 2CSPC INNOVATION PHARMACEUTICAL CO., LTD. Shijiazhuang City CN
01 2Theobromine - Text Deleted 1/07/2021
01 2China
01 1Expired
02 1Withdrawn by EDQM Failure to CEP procedure
Theobromine - Text Deleted 1/07/2021
Certificate Number : R0-CEP 2010-168 - Rev 00
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2011-07-27
Type : Chemical
Substance Number :
Theobromine - Text Deleted 1/07/2021
Certificate Number : R0-CEP 2014-228 - Rev 00
Status : Expired
Issue Date : 2016-05-20
Type : Chemical
Substance Number :
A Theobromine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Theobromine, including repackagers and relabelers. The FDA regulates Theobromine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Theobromine 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 Theobromine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Theobromine supplier is an individual or a company that provides Theobromine active pharmaceutical ingredient (API) or Theobromine finished formulations upon request. The Theobromine suppliers may include Theobromine API manufacturers, exporters, distributors and traders.
click here to find a list of Theobromine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Theobromine CEP of the European Pharmacopoeia monograph is often referred to as a Theobromine Certificate of Suitability (COS). The purpose of a Theobromine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Theobromine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Theobromine to their clients by showing that a Theobromine CEP has been issued for it. The manufacturer submits a Theobromine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Theobromine CEP holder for the record. Additionally, the data presented in the Theobromine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Theobromine DMF.
A Theobromine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Theobromine 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 Theobromine suppliers with CEP (COS) on PharmaCompass.
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