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