01 1Nissan Chemical
01 1NTC-801F
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23151
Submission : 2009-10-06
Status : Inactive
Type : II
A Ntc manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ntc, including repackagers and relabelers. The FDA regulates Ntc manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ntc API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Ntc supplier is an individual or a company that provides Ntc active pharmaceutical ingredient (API) or Ntc finished formulations upon request. The Ntc suppliers may include Ntc API manufacturers, exporters, distributors and traders.
click here to find a list of Ntc suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ntc DMF (Drug Master File) is a document detailing the whole manufacturing process of Ntc active pharmaceutical ingredient (API) in detail. Different forms of Ntc DMFs exist exist since differing nations have different regulations, such as Ntc USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ntc DMF submitted to regulatory agencies in the US is known as a USDMF. Ntc USDMF includes data on Ntc's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ntc USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ntc suppliers with USDMF on PharmaCompass.
LOOKING FOR A SUPPLIER?