01 1Industriale Chimica
01 1BENZBROMARONE BULK
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2903
Submission : 1977-03-22
Status : Inactive
Type : II
A Benzbromarone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benzbromarone, including repackagers and relabelers. The FDA regulates Benzbromarone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benzbromarone 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 Benzbromarone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Benzbromarone supplier is an individual or a company that provides Benzbromarone active pharmaceutical ingredient (API) or Benzbromarone finished formulations upon request. The Benzbromarone suppliers may include Benzbromarone API manufacturers, exporters, distributors and traders.
click here to find a list of Benzbromarone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benzbromarone DMF (Drug Master File) is a document detailing the whole manufacturing process of Benzbromarone active pharmaceutical ingredient (API) in detail. Different forms of Benzbromarone DMFs exist exist since differing nations have different regulations, such as Benzbromarone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benzbromarone DMF submitted to regulatory agencies in the US is known as a USDMF. Benzbromarone USDMF includes data on Benzbromarone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benzbromarone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Benzbromarone suppliers with USDMF on PharmaCompass.
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