01 1Sumitomo Pharma
01 1SM-5887 (AMRUBICIN HYDROCHLORIDE)
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18990
Submission : 2005-11-30
Status : Inactive
Type : II
A Amrubicin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amrubicin, including repackagers and relabelers. The FDA regulates Amrubicin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amrubicin 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 Amrubicin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amrubicin supplier is an individual or a company that provides Amrubicin active pharmaceutical ingredient (API) or Amrubicin finished formulations upon request. The Amrubicin suppliers may include Amrubicin API manufacturers, exporters, distributors and traders.
click here to find a list of Amrubicin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amrubicin DMF (Drug Master File) is a document detailing the whole manufacturing process of Amrubicin active pharmaceutical ingredient (API) in detail. Different forms of Amrubicin DMFs exist exist since differing nations have different regulations, such as Amrubicin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amrubicin DMF submitted to regulatory agencies in the US is known as a USDMF. Amrubicin USDMF includes data on Amrubicin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amrubicin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amrubicin suppliers with USDMF on PharmaCompass.
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