01 1KUNSHAN ORIENTAL PHARMACEUTICAL CO LTD
02 1Recordati
01 2PHENYTOIN
01 1China
02 1Italy
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20434
Submission : 2007-03-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23226
Submission : 2009-10-29
Status : Active
Type : II
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PharmaCompass offers a list of Phenytoin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Phenytoin manufacturer or Phenytoin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Phenytoin manufacturer or Phenytoin supplier.
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, and COA 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, and COA related information on PharmaCompass.
A Phenytoin DMF (Drug Master File) is a document detailing the whole manufacturing process of Phenytoin active pharmaceutical ingredient (API) in detail. Different forms of Phenytoin DMFs exist exist since differing nations have different regulations, such as Phenytoin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phenytoin DMF submitted to regulatory agencies in the US is known as a USDMF. Phenytoin USDMF includes data on Phenytoin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phenytoin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phenytoin suppliers with USDMF on PharmaCompass.
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