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
57
PharmaCompass offers a list of Nicotinamide 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 Nicotinamide manufacturer or Nicotinamide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nicotinamide manufacturer or Nicotinamide supplier.
PharmaCompass also assists you with knowing the Nicotinamide API Price utilized in the formulation of products. Nicotinamide API Price is not always fixed or binding as the Nicotinamide Price is obtained through a variety of data sources. The Nicotinamide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A N0078 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N0078, including repackagers and relabelers. The FDA regulates N0078 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N0078 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 N0078 supplier is an individual or a company that provides N0078 active pharmaceutical ingredient (API) or N0078 finished formulations upon request. The N0078 suppliers may include N0078 API manufacturers, exporters, distributors and traders.
click here to find a list of N0078 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A N0078 DMF (Drug Master File) is a document detailing the whole manufacturing process of N0078 active pharmaceutical ingredient (API) in detail. Different forms of N0078 DMFs exist exist since differing nations have different regulations, such as N0078 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A N0078 DMF submitted to regulatory agencies in the US is known as a USDMF. N0078 USDMF includes data on N0078's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The N0078 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of N0078 suppliers with USDMF on PharmaCompass.
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