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