01 2Daiichi Sankyo
01 1BULK FORM OF NIMUSTINE HCL (NIDRAN)
02 1NIMUSTINE HCL (NIDRAN) IN VIALS
01 2Japan
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5468
Submission : 1984-07-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5461
Submission : 1984-07-20
Status : Inactive
Type : II
100
PharmaCompass offers a list of Nimustine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Nimustine manufacturer or Nimustine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nimustine manufacturer or Nimustine supplier.
A Nimustine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nimustine, including repackagers and relabelers. The FDA regulates Nimustine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nimustine 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 Nimustine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Nimustine supplier is an individual or a company that provides Nimustine active pharmaceutical ingredient (API) or Nimustine finished formulations upon request. The Nimustine suppliers may include Nimustine API manufacturers, exporters, distributors and traders.
click here to find a list of Nimustine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Nimustine DMF (Drug Master File) is a document detailing the whole manufacturing process of Nimustine active pharmaceutical ingredient (API) in detail. Different forms of Nimustine DMFs exist exist since differing nations have different regulations, such as Nimustine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nimustine DMF submitted to regulatory agencies in the US is known as a USDMF. Nimustine USDMF includes data on Nimustine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nimustine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nimustine suppliers with USDMF on PharmaCompass.
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