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