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