01 1F. Hoffmann-La Roche
01 1SEARLE ANTACID
01 1Switzerland
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3352
Submission : 1978-10-20
Status : Inactive
Type : II
A Nufenoxole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nufenoxole, including repackagers and relabelers. The FDA regulates Nufenoxole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nufenoxole 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 Nufenoxole supplier is an individual or a company that provides Nufenoxole active pharmaceutical ingredient (API) or Nufenoxole finished formulations upon request. The Nufenoxole suppliers may include Nufenoxole API manufacturers, exporters, distributors and traders.
click here to find a list of Nufenoxole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nufenoxole DMF (Drug Master File) is a document detailing the whole manufacturing process of Nufenoxole active pharmaceutical ingredient (API) in detail. Different forms of Nufenoxole DMFs exist exist since differing nations have different regulations, such as Nufenoxole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nufenoxole DMF submitted to regulatory agencies in the US is known as a USDMF. Nufenoxole USDMF includes data on Nufenoxole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nufenoxole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nufenoxole suppliers with USDMF on PharmaCompass.
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