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