01 1Actavis Inc
02 1Aurobindo Pharma Limited
03 1CEPHALON INC
04 1Lupin Ltd
05 1Orchid Pharma
06 1Piramal Pharma Solutions
07 1SAFC
08 2Teva Pharmaceutical Industries
09 1Unimark Remedies Limited
10 1Viatris
01 7ARMODAFINIL
02 1ARMODAFINIL (NON STERILE BULK DRUG SUBSTANCE)
03 1ARMODAFINIL 7SM1029
04 2ARMODAFINIL DRUG SUBSTANCE
01 4India
02 1Ireland
03 2Israel
04 4U.S.A
01 9Active
02 2Inactive
01 3Complete
02 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22983
Submission : 2009-07-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2013-07-24
DMF Number : 27302
Submission : 2013-07-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19685
Submission : 2006-08-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23134
Submission : 2009-10-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25031
Submission : 2011-06-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30405
Submission : 2016-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18107
Submission : 2005-02-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30350
Submission : 2016-04-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-05
Pay. Date : 2014-01-22
DMF Number : 24945
Submission : 2011-06-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-05-02
Pay. Date : 2017-04-20
DMF Number : 21200
Submission : 2007-12-19
Status : Active
Type : II
A Nuvigil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nuvigil, including repackagers and relabelers. The FDA regulates Nuvigil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nuvigil 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 Nuvigil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nuvigil supplier is an individual or a company that provides Nuvigil active pharmaceutical ingredient (API) or Nuvigil finished formulations upon request. The Nuvigil suppliers may include Nuvigil API manufacturers, exporters, distributors and traders.
click here to find a list of Nuvigil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nuvigil DMF (Drug Master File) is a document detailing the whole manufacturing process of Nuvigil active pharmaceutical ingredient (API) in detail. Different forms of Nuvigil DMFs exist exist since differing nations have different regulations, such as Nuvigil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nuvigil DMF submitted to regulatory agencies in the US is known as a USDMF. Nuvigil USDMF includes data on Nuvigil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nuvigil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nuvigil suppliers with USDMF on PharmaCompass.
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