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