01 1Meiji Seika Pharma
01 1ARBEKACIN FREE BASE DRUG SUBSTANCE (ME1100)
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26098
Submission : 2012-06-08
Status : Inactive
Type : II
A Arbekacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Arbekacin, including repackagers and relabelers. The FDA regulates Arbekacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Arbekacin 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 Arbekacin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Arbekacin supplier is an individual or a company that provides Arbekacin active pharmaceutical ingredient (API) or Arbekacin finished formulations upon request. The Arbekacin suppliers may include Arbekacin API manufacturers, exporters, distributors and traders.
click here to find a list of Arbekacin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Arbekacin DMF (Drug Master File) is a document detailing the whole manufacturing process of Arbekacin active pharmaceutical ingredient (API) in detail. Different forms of Arbekacin DMFs exist exist since differing nations have different regulations, such as Arbekacin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Arbekacin DMF submitted to regulatory agencies in the US is known as a USDMF. Arbekacin USDMF includes data on Arbekacin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Arbekacin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Arbekacin suppliers with USDMF on PharmaCompass.
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