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