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