01 1Bausch Health
01 1MOGADON (NITRAZEPAM) TABLETS
01 1Canada
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13151
Submission : 1998-08-24
Status : Inactive
Type : II
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PharmaCompass offers a list of Nitrazepam 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 Nitrazepam manufacturer or Nitrazepam supplier for your needs.
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A Nitrazep manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitrazep, including repackagers and relabelers. The FDA regulates Nitrazep manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitrazep 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 Nitrazep manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Nitrazep supplier is an individual or a company that provides Nitrazep active pharmaceutical ingredient (API) or Nitrazep finished formulations upon request. The Nitrazep suppliers may include Nitrazep API manufacturers, exporters, distributors and traders.
click here to find a list of Nitrazep suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Nitrazep DMF (Drug Master File) is a document detailing the whole manufacturing process of Nitrazep active pharmaceutical ingredient (API) in detail. Different forms of Nitrazep DMFs exist exist since differing nations have different regulations, such as Nitrazep USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nitrazep DMF submitted to regulatory agencies in the US is known as a USDMF. Nitrazep USDMF includes data on Nitrazep's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nitrazep USDMF is kept confidential to protect the manufacturer’s intellectual property.
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