01 1Aarti Drugs
02 1Divis Laboratories
03 1F. Hoffmann-La Roche
04 1Jubilant Generics
05 2Lonza Group
06 1Upsher-Smith Laboratories
07 1Vertellus
08 1Wockhardt
01 2NIACIN
02 3NIACIN USP
03 1NIACIN USP GRANULAR SPECIAL
04 1NIACIN USP SPECIAL
05 1NIACOR (IMMEDIATE-RELEASE NIACIN TABLETS)
06 1NICOTINIC ACID CAPSULES 125,250, & 500MG
01 4India
02 3Switzerland
03 2U.S.A
01 4Active
02 5Inactive
01 3Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-10
Pay. Date : 2013-04-03
DMF Number : 20051
Submission : 2006-12-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-08
Pay. Date : 2012-12-06
DMF Number : 18481
Submission : 2005-07-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4404
Submission : 1982-01-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31382
Submission : 2017-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8041
Submission : 1989-04-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18293
Submission : 2005-04-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10523
Submission : 1993-10-07
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-12
Pay. Date : 2022-09-28
DMF Number : 8259
Submission : 1989-10-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7642
Submission : 1988-08-23
Status : Inactive
Type : II
A Niaspan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Niaspan, including repackagers and relabelers. The FDA regulates Niaspan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Niaspan 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 Niaspan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Niaspan supplier is an individual or a company that provides Niaspan active pharmaceutical ingredient (API) or Niaspan finished formulations upon request. The Niaspan suppliers may include Niaspan API manufacturers, exporters, distributors and traders.
click here to find a list of Niaspan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Niaspan DMF (Drug Master File) is a document detailing the whole manufacturing process of Niaspan active pharmaceutical ingredient (API) in detail. Different forms of Niaspan DMFs exist exist since differing nations have different regulations, such as Niaspan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Niaspan DMF submitted to regulatory agencies in the US is known as a USDMF. Niaspan USDMF includes data on Niaspan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Niaspan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Niaspan suppliers with USDMF on PharmaCompass.
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