01 1SAFC
01 1FENBENDAZOLE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11755
Submission : 1995-11-27
Status : Inactive
Type : II
A Fenbendazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fenbendazole, including repackagers and relabelers. The FDA regulates Fenbendazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fenbendazole 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 Fenbendazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fenbendazole supplier is an individual or a company that provides Fenbendazole active pharmaceutical ingredient (API) or Fenbendazole finished formulations upon request. The Fenbendazole suppliers may include Fenbendazole API manufacturers, exporters, distributors and traders.
click here to find a list of Fenbendazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fenbendazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Fenbendazole active pharmaceutical ingredient (API) in detail. Different forms of Fenbendazole DMFs exist exist since differing nations have different regulations, such as Fenbendazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fenbendazole DMF submitted to regulatory agencies in the US is known as a USDMF. Fenbendazole USDMF includes data on Fenbendazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fenbendazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fenbendazole suppliers with USDMF on PharmaCompass.
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