01 1EDMOND PHARMA S.R.L. Paderno Dugnano IT
01 1Terfenadine
01 1Italy
01 1Expired
Certificate Number : R1-CEP 1997-010 - Rev 01
Status : Expired
Issue Date : 2004-10-28
Type : Chemical
Substance Number : 955
A Terfenadine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Terfenadine, including repackagers and relabelers. The FDA regulates Terfenadine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Terfenadine 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 Terfenadine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Terfenadine supplier is an individual or a company that provides Terfenadine active pharmaceutical ingredient (API) or Terfenadine finished formulations upon request. The Terfenadine suppliers may include Terfenadine API manufacturers, exporters, distributors and traders.
click here to find a list of Terfenadine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Terfenadine CEP of the European Pharmacopoeia monograph is often referred to as a Terfenadine Certificate of Suitability (COS). The purpose of a Terfenadine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Terfenadine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Terfenadine to their clients by showing that a Terfenadine CEP has been issued for it. The manufacturer submits a Terfenadine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Terfenadine CEP holder for the record. Additionally, the data presented in the Terfenadine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Terfenadine DMF.
A Terfenadine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Terfenadine 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 Terfenadine suppliers with CEP (COS) on PharmaCompass.
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