LEBSA- Your strategic API source for niche molecules.
01 1Laboratorios Espinos Y Bofill S.A. Cornella de Llobregat ES
02 1PCAS Longjumeau FR
01 2Betahistine mesilate
01 1France
02 1Spain
01 1Valid
02 1Withdrawn by Holder
LEBSA- Your strategic API source for niche molecules.
LEBSA- Your strategic API source for niche molecules.
Certificate Number : CEP 2023-447 - Rev 00
Status : Valid
Issue Date : 2024-09-26
Type : Chemical
Substance Number : 1071
Certificate Number : R0-CEP 1999-052 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2002-04-10
Type : Chemical
Substance Number : 1071
A Betahistine Dimesilate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betahistine Dimesilate, including repackagers and relabelers. The FDA regulates Betahistine Dimesilate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betahistine Dimesilate 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 Betahistine Dimesilate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Betahistine Dimesilate supplier is an individual or a company that provides Betahistine Dimesilate active pharmaceutical ingredient (API) or Betahistine Dimesilate finished formulations upon request. The Betahistine Dimesilate suppliers may include Betahistine Dimesilate API manufacturers, exporters, distributors and traders.
click here to find a list of Betahistine Dimesilate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Betahistine Dimesilate CEP of the European Pharmacopoeia monograph is often referred to as a Betahistine Dimesilate Certificate of Suitability (COS). The purpose of a Betahistine Dimesilate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Betahistine Dimesilate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Betahistine Dimesilate to their clients by showing that a Betahistine Dimesilate CEP has been issued for it. The manufacturer submits a Betahistine Dimesilate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Betahistine Dimesilate CEP holder for the record. Additionally, the data presented in the Betahistine Dimesilate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Betahistine Dimesilate DMF.
A Betahistine Dimesilate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Betahistine Dimesilate 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 Betahistine Dimesilate suppliers with CEP (COS) on PharmaCompass.
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