01 1AURORE PHARMACEUTICALS PRIVATE LIMITED
02 1Aurobindo Pharma Limited
03 1F.I.S. FABBRICA ITALIANA SINTETICI S.P.A.
04 1Mylan Laboratories Limited
05 1Piramal Pharma Limited
06 1Pliva Croatia Ltd
07 1ScinoPharm Taiwan Ltd.
08 1TAPI Croatia Industries Ltd.
09 1Tianish Laboratories Private Limited
01 3ARMODAFINIL
02 1ARMODANFINIL
03 5Armodafinil
01 1Croatia
02 3India
03 1Italy
04 1Taiwan
05 2U.S.A
06 1Blank
NDC Package Code : 65862-795
Start Marketing Date : 2023-11-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 72761-001
Start Marketing Date : 2019-02-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 48087-0066
Start Marketing Date : 2010-04-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65085-0058
Start Marketing Date : 2022-07-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 11722-072
Start Marketing Date : 2020-07-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 65129-1185
Start Marketing Date : 2006-07-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 84206-0010
Start Marketing Date : 2024-08-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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
NDC Package Code : 11722-055
Start Marketing Date : 2014-07-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
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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.
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.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Nuvigil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nuvigil API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Nuvigil as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Nuvigil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nuvigil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nuvigil suppliers with NDC on PharmaCompass.
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