01 1KATWIJK CHEMIE BV Katwijk ZH NL
01 1Phenytoin
01 1Netherlands
01 1Valid
Certificate Number : R1-CEP 2010-244 - Rev 01
Status : Valid
Issue Date : 2018-11-05
Type : Chemical
Substance Number : 1253
A Phenytoin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenytoin, including repackagers and relabelers. The FDA regulates Phenytoin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenytoin 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 Phenytoin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phenytoin supplier is an individual or a company that provides Phenytoin active pharmaceutical ingredient (API) or Phenytoin finished formulations upon request. The Phenytoin suppliers may include Phenytoin API manufacturers, exporters, distributors and traders.
click here to find a list of Phenytoin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phenytoin CEP of the European Pharmacopoeia monograph is often referred to as a Phenytoin Certificate of Suitability (COS). The purpose of a Phenytoin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Phenytoin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Phenytoin to their clients by showing that a Phenytoin CEP has been issued for it. The manufacturer submits a Phenytoin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Phenytoin CEP holder for the record. Additionally, the data presented in the Phenytoin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Phenytoin DMF.
A Phenytoin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Phenytoin 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 Phenytoin suppliers with CEP (COS) on PharmaCompass.
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