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