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