01 1Sumitomo Chemical
01 1SM-8668
01 1Japan
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8210
Submission : 1989-09-18
Status : Inactive
Type : II
A Genaconazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Genaconazole, including repackagers and relabelers. The FDA regulates Genaconazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Genaconazole 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 Genaconazole supplier is an individual or a company that provides Genaconazole active pharmaceutical ingredient (API) or Genaconazole finished formulations upon request. The Genaconazole suppliers may include Genaconazole API manufacturers, exporters, distributors and traders.
click here to find a list of Genaconazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Genaconazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Genaconazole active pharmaceutical ingredient (API) in detail. Different forms of Genaconazole DMFs exist exist since differing nations have different regulations, such as Genaconazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Genaconazole DMF submitted to regulatory agencies in the US is known as a USDMF. Genaconazole USDMF includes data on Genaconazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Genaconazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Genaconazole suppliers with USDMF on PharmaCompass.
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