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