01 1Lonza Group
01 1CN25225 (METEXAFIN GADOLINIUM)
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15729
Submission : 2001-11-15
Status : Inactive
Type : II
A Motexafin Gadolinium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Motexafin Gadolinium, including repackagers and relabelers. The FDA regulates Motexafin Gadolinium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Motexafin Gadolinium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Motexafin Gadolinium supplier is an individual or a company that provides Motexafin Gadolinium active pharmaceutical ingredient (API) or Motexafin Gadolinium finished formulations upon request. The Motexafin Gadolinium suppliers may include Motexafin Gadolinium API manufacturers, exporters, distributors and traders.
click here to find a list of Motexafin Gadolinium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Motexafin Gadolinium DMF (Drug Master File) is a document detailing the whole manufacturing process of Motexafin Gadolinium active pharmaceutical ingredient (API) in detail. Different forms of Motexafin Gadolinium DMFs exist exist since differing nations have different regulations, such as Motexafin Gadolinium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Motexafin Gadolinium DMF submitted to regulatory agencies in the US is known as a USDMF. Motexafin Gadolinium USDMF includes data on Motexafin Gadolinium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Motexafin Gadolinium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Motexafin Gadolinium suppliers with USDMF on PharmaCompass.
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