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