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01 1Laboratorios Espinos Y Bofill S.A. Cornella de Llobregat ES
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01 1Betahistine mesilate
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01 1Spain
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01 1Valid
Certificate Number : CEP 2023-447 - Rev 00
Status : Valid
Issue Date : 2024-09-26
Type : Chemical
Substance Number : 1071
20
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A Extovyl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Extovyl, including repackagers and relabelers. The FDA regulates Extovyl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Extovyl 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 Extovyl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Extovyl supplier is an individual or a company that provides Extovyl active pharmaceutical ingredient (API) or Extovyl finished formulations upon request. The Extovyl suppliers may include Extovyl API manufacturers, exporters, distributors and traders.
click here to find a list of Extovyl suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Extovyl CEP of the European Pharmacopoeia monograph is often referred to as a Extovyl Certificate of Suitability (COS). The purpose of a Extovyl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Extovyl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Extovyl to their clients by showing that a Extovyl CEP has been issued for it. The manufacturer submits a Extovyl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Extovyl CEP holder for the record. Additionally, the data presented in the Extovyl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Extovyl DMF.
A Extovyl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Extovyl 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 Extovyl suppliers with CEP (COS) on PharmaCompass.