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