01 1Apicore LLC
02 1Emcure Pharmaceuticals
03 1Enaltec Labs Private Limited
04 1Fujifilm Diosynth Biotechnologies
05 1Hetero Drugs
06 1Procos
07 1Raks Pharma
08 1Siegfried AG
09 1Solara Active Pharma Sciences
10 1Taro Pharmaceutical Industries
11 2Viatris
12 1Blank
01 12-PHENYL-1,3-PROPANEDIOL DICARBAMATE
02 6FELBAMATE
03 4FELBAMATE USP
04 1FELBAMATE USP (FEL)
05 1FELBAMATE, USP
01 6India
02 1Italy
03 1Switzerland
04 3U.S.A
05 1United Kingdom
06 1Blank
01 8Active
02 5Inactive
01 6Complete
02 7Blank
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-02
Pay. Date : 2015-07-08
DMF Number : 29408
Submission : 2015-06-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7267
Submission : 1987-12-29
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-03
Pay. Date : 2015-02-13
DMF Number : 21247
Submission : 2008-01-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-27
Pay. Date : 2016-12-27
DMF Number : 31181
Submission : 2016-12-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8304
Submission : 1989-11-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-07-25
Pay. Date : 2024-07-18
DMF Number : 22810
Submission : 2009-06-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-06
Pay. Date : 2013-11-06
DMF Number : 27331
Submission : 2013-11-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39207
Submission : 2023-12-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-29
Pay. Date : 2015-01-19
DMF Number : 22958
Submission : 2009-07-15
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9352
Submission : 1991-09-16
Status : Inactive
Type : II
Portfolio PDF
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Corporate PDF
A Felbamate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Felbamate, including repackagers and relabelers. The FDA regulates Felbamate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Felbamate 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 Felbamate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Felbamate supplier is an individual or a company that provides Felbamate active pharmaceutical ingredient (API) or Felbamate finished formulations upon request. The Felbamate suppliers may include Felbamate API manufacturers, exporters, distributors and traders.
click here to find a list of Felbamate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Felbamate DMF (Drug Master File) is a document detailing the whole manufacturing process of Felbamate active pharmaceutical ingredient (API) in detail. Different forms of Felbamate DMFs exist exist since differing nations have different regulations, such as Felbamate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Felbamate DMF submitted to regulatory agencies in the US is known as a USDMF. Felbamate USDMF includes data on Felbamate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Felbamate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Felbamate suppliers with USDMF on PharmaCompass.
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