01 1Corden Pharma Bergamo S.p.A
01 1N-METHYL-1-METHYLTHIO-2-NITRO ETHENAMINE, TREVIGLIO, ITALY
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7515
Submission : 1988-05-19
Status : Inactive
Type : II
A Unii-856Lu0Gv8H manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Unii-856Lu0Gv8H, including repackagers and relabelers. The FDA regulates Unii-856Lu0Gv8H manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Unii-856Lu0Gv8H 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 Unii-856Lu0Gv8H supplier is an individual or a company that provides Unii-856Lu0Gv8H active pharmaceutical ingredient (API) or Unii-856Lu0Gv8H finished formulations upon request. The Unii-856Lu0Gv8H suppliers may include Unii-856Lu0Gv8H API manufacturers, exporters, distributors and traders.
click here to find a list of Unii-856Lu0Gv8H suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Unii-856Lu0Gv8H DMF (Drug Master File) is a document detailing the whole manufacturing process of Unii-856Lu0Gv8H active pharmaceutical ingredient (API) in detail. Different forms of Unii-856Lu0Gv8H DMFs exist exist since differing nations have different regulations, such as Unii-856Lu0Gv8H USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Unii-856Lu0Gv8H DMF submitted to regulatory agencies in the US is known as a USDMF. Unii-856Lu0Gv8H USDMF includes data on Unii-856Lu0Gv8H's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Unii-856Lu0Gv8H USDMF is kept confidential to protect the manufacturer’s intellectual property.
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