01 1HARMAN FINOCHEM LIMITED Mumbai IN
02 1KATWIJK CHEMIE BV Katwijk ZH NL
01 2Phenytoin sodium
01 1India
02 1Netherlands
01 2Valid
Certificate Number : R1-CEP 2016-038 - Rev 00
Status : Valid
Issue Date : 2023-01-11
Type : Chemical
Substance Number : 521
Certificate Number : R1-CEP 2015-151 - Rev 00
Status : Valid
Issue Date : 2020-10-14
Type : Chemical
Substance Number : 521
A Phenytoin Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phenytoin Sodium, including repackagers and relabelers. The FDA regulates Phenytoin Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phenytoin Sodium 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 Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phenytoin Sodium supplier is an individual or a company that provides Phenytoin Sodium active pharmaceutical ingredient (API) or Phenytoin Sodium finished formulations upon request. The Phenytoin Sodium suppliers may include Phenytoin Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Phenytoin Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phenytoin Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Phenytoin Sodium Certificate of Suitability (COS). The purpose of a Phenytoin Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Phenytoin Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Phenytoin Sodium to their clients by showing that a Phenytoin Sodium CEP has been issued for it. The manufacturer submits a Phenytoin Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Phenytoin Sodium CEP holder for the record. Additionally, the data presented in the Phenytoin Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Phenytoin Sodium DMF.
A Phenytoin Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Phenytoin Sodium 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 Sodium suppliers with CEP (COS) on PharmaCompass.
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