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