01 2Lonza Group
02 1Vertellus
03 2Yuki Gosei Kogyo
01 1MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES OF NIACINAMIDE IN JOBAN, IWAKI-CITY, FUKUSHIMA PREFECTURE, JAPAN.
02 2NIACINAMIDE
03 1NIACINAMIDE FOR ORAL USE
04 1NIACINAMIDE USP
01 2Japan
02 2Switzerland
03 1U.S.A
01 1Active
02 4Inactive
01 1Complete
02 4Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-26
Pay. Date : 2016-09-30
DMF Number : 30711
Submission : 2016-06-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11119
Submission : 1994-09-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14882
Submission : 2000-05-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10173
Submission : 1993-03-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4787
Submission : 1982-12-07
Status : Inactive
Type : II
A Nicotinamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nicotinamide, including repackagers and relabelers. The FDA regulates Nicotinamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nicotinamide 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 Nicotinamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nicotinamide supplier is an individual or a company that provides Nicotinamide active pharmaceutical ingredient (API) or Nicotinamide finished formulations upon request. The Nicotinamide suppliers may include Nicotinamide API manufacturers, exporters, distributors and traders.
click here to find a list of Nicotinamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nicotinamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Nicotinamide active pharmaceutical ingredient (API) in detail. Different forms of Nicotinamide DMFs exist exist since differing nations have different regulations, such as Nicotinamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nicotinamide DMF submitted to regulatory agencies in the US is known as a USDMF. Nicotinamide USDMF includes data on Nicotinamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nicotinamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nicotinamide suppliers with USDMF on PharmaCompass.
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