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
84
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A Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride, including repackagers and relabelers. The FDA regulates Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride 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 Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride supplier is an individual or a company that provides Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride active pharmaceutical ingredient (API) or Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride finished formulations upon request. The Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride suppliers may include Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride DMFs exist exist since differing nations have different regulations, such as Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride USDMF includes data on Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride suppliers with USDMF on PharmaCompass.
We have 1 companies offering Urea, N'-((4-amino-2-methyl-5-pyrimidinyl)methyl)-N-(2-chloroethyl)-N-nitroso-, monohydrochloride
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