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