01 1Borregaard
01 1REDUCED ALKYLATED IMIDAZOLE
01 1Norway
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15969
Submission : 2002-05-06
Status : Inactive
Type : II
A Imidazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Imidazole, including repackagers and relabelers. The FDA regulates Imidazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Imidazole 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 Imidazole supplier is an individual or a company that provides Imidazole active pharmaceutical ingredient (API) or Imidazole finished formulations upon request. The Imidazole suppliers may include Imidazole API manufacturers, exporters, distributors and traders.
click here to find a list of Imidazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Imidazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Imidazole active pharmaceutical ingredient (API) in detail. Different forms of Imidazole DMFs exist exist since differing nations have different regulations, such as Imidazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Imidazole DMF submitted to regulatory agencies in the US is known as a USDMF. Imidazole USDMF includes data on Imidazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Imidazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Imidazole suppliers with USDMF on PharmaCompass.
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