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 Niacinamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Niacinamide, including repackagers and relabelers. The FDA regulates Niacinamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Niacinamide 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 Niacinamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Niacinamide supplier is an individual or a company that provides Niacinamide active pharmaceutical ingredient (API) or Niacinamide finished formulations upon request. The Niacinamide suppliers may include Niacinamide API manufacturers, exporters, distributors and traders.
click here to find a list of Niacinamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Niacinamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Niacinamide active pharmaceutical ingredient (API) in detail. Different forms of Niacinamide DMFs exist exist since differing nations have different regulations, such as Niacinamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Niacinamide DMF submitted to regulatory agencies in the US is known as a USDMF. Niacinamide USDMF includes data on Niacinamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Niacinamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Niacinamide suppliers with USDMF on PharmaCompass.
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