01 1Cadila Pharmaceuticals
02 1Divis Laboratories
03 1EASTMAN KODAK
04 1ERREDUE S.P.A. IT 24040 Isso
05 1Harman Finochem
06 1KUNSHAN ORIENTAL PHARMACEUTICAL CO LTD
07 1Katwijk Chemie
08 1Orchid Pharma
09 1Pfizer Inc
10 2Recordati
11 1Unichem Laboratories Limited
01 15-PHENYLHYDANTOIN
02 1AML ASEPTIC PROCESSING WAREHOUSING AND LABORATORIES
03 1PHENYTOIN MICRO
04 4PHENYTOIN SODIUM
05 2PHENYTOIN SODIUM USP
06 2PHENYTOIN USP & PHENYTOIN SODIUM USP
07 1PHENYTOIN/PHENYTOIN SODIUM
01 1China
02 5India
03 3Italy
04 1Netherlands
05 2U.S.A
01 8Active
02 4Inactive
01 4Complete
02 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7304
Submission : 1988-01-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16301
Submission : 2002-12-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-14
Pay. Date : 2015-09-30
DMF Number : 17862
Submission : 2004-12-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-28
Pay. Date : 2015-09-15
DMF Number : 5384
Submission : 1984-06-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20433
Submission : 2007-03-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20453
Submission : 2007-04-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7229
Submission : 1987-11-20
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-10-18
Pay. Date : 2024-10-15
DMF Number : 4538
Submission : 1982-04-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4531
Submission : 1982-04-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-05-31
Pay. Date : 2018-03-27
DMF Number : 32676
Submission : 2018-03-29
Status : Active
Type : II
A Dilantin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dilantin, including repackagers and relabelers. The FDA regulates Dilantin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dilantin 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 Dilantin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dilantin supplier is an individual or a company that provides Dilantin active pharmaceutical ingredient (API) or Dilantin finished formulations upon request. The Dilantin suppliers may include Dilantin API manufacturers, exporters, distributors and traders.
click here to find a list of Dilantin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dilantin DMF (Drug Master File) is a document detailing the whole manufacturing process of Dilantin active pharmaceutical ingredient (API) in detail. Different forms of Dilantin DMFs exist exist since differing nations have different regulations, such as Dilantin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dilantin DMF submitted to regulatory agencies in the US is known as a USDMF. Dilantin USDMF includes data on Dilantin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dilantin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dilantin suppliers with USDMF on PharmaCompass.
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