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GDUFA
DMF Review : Reviewed
Rev. Date : 2017-05-02
Pay. Date : 2017-04-20
DMF Number : 21200
Submission : 2007-12-19
Status : Active
Type : II
Date of Issue : 2022-06-22
Valid Till : 2025-07-28
Written Confirmation Number : WC-0117
Address of the Firm :
NDC Package Code : 65015-784
Start Marketing Date : 2015-01-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22983
Submission : 2009-07-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30405
Submission : 2016-03-31
Status : Active
Type : II
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0123
Address of the Firm :
NDC Package Code : 65085-0058
Start Marketing Date : 2022-07-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : Reviewed
Rev. Date : 2014-08-05
Pay. Date : 2014-01-22
DMF Number : 24945
Submission : 2011-06-01
Status : Active
Type : II
Date of Issue : 2024-04-23
Valid Till : 2027-04-22
Written Confirmation Number : WC-0170
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-28
Pay. Date : 2013-07-24
DMF Number : 27302
Submission : 2013-07-29
Status : Active
Type : II
NDC Package Code : 65862-795
Start Marketing Date : 2023-11-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
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 : 18107
Submission : 2005-02-21
Status : Inactive
Type : II
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PharmaCompass offers a list of Armodafinil API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Armodafinil manufacturer or Armodafinil supplier for your needs.
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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.
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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.
We have 23 companies offering Nuvigil
Get in contact with the supplier of your choice: