01 1Synteco S.p.A. San Martino Siccomario IT
01 1Benfluorex hydrochloride
01 1Italy
01 1Expired
Certificate Number : R0-CEP 2002-092 - Rev 02
Status : Expired
Issue Date : 2005-06-02
Type : Chemical
Substance Number : 1601
A Benfluorex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benfluorex, including repackagers and relabelers. The FDA regulates Benfluorex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benfluorex API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Benfluorex supplier is an individual or a company that provides Benfluorex active pharmaceutical ingredient (API) or Benfluorex finished formulations upon request. The Benfluorex suppliers may include Benfluorex API manufacturers, exporters, distributors and traders.
click here to find a list of Benfluorex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benfluorex CEP of the European Pharmacopoeia monograph is often referred to as a Benfluorex Certificate of Suitability (COS). The purpose of a Benfluorex CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Benfluorex EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Benfluorex to their clients by showing that a Benfluorex CEP has been issued for it. The manufacturer submits a Benfluorex CEP (COS) as part of the market authorization procedure, and it takes on the role of a Benfluorex CEP holder for the record. Additionally, the data presented in the Benfluorex CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Benfluorex DMF.
A Benfluorex CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Benfluorex 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 Benfluorex suppliers with CEP (COS) on PharmaCompass.
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