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.
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A Dilantine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dilantine, including repackagers and relabelers. The FDA regulates Dilantine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dilantine 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 Dilantine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Dilantine supplier is an individual or a company that provides Dilantine active pharmaceutical ingredient (API) or Dilantine finished formulations upon request. The Dilantine suppliers may include Dilantine API manufacturers, exporters, distributors and traders.
click here to find a list of Dilantine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Dilantine DMF (Drug Master File) is a document detailing the whole manufacturing process of Dilantine active pharmaceutical ingredient (API) in detail. Different forms of Dilantine DMFs exist exist since differing nations have different regulations, such as Dilantine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dilantine DMF submitted to regulatory agencies in the US is known as a USDMF. Dilantine USDMF includes data on Dilantine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dilantine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dilantine suppliers with USDMF on PharmaCompass.
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