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01 1NITROXOLINE
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01 1Active
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43467
Submission : 2026-01-23
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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PharmaCompass offers a list of Nitroxoline API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Nitroxoline manufacturer or Nitroxoline supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nitroxoline manufacturer or Nitroxoline supplier.
A Nitroxoline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitroxoline, including repackagers and relabelers. The FDA regulates Nitroxoline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitroxoline 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 Nitroxoline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Nitroxoline supplier is an individual or a company that provides Nitroxoline active pharmaceutical ingredient (API) or Nitroxoline finished formulations upon request. The Nitroxoline suppliers may include Nitroxoline API manufacturers, exporters, distributors and traders.
click here to find a list of Nitroxoline suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Nitroxoline DMF (Drug Master File) is a document detailing the whole manufacturing process of Nitroxoline active pharmaceutical ingredient (API) in detail. Different forms of Nitroxoline DMFs exist exist since differing nations have different regulations, such as Nitroxoline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nitroxoline DMF submitted to regulatory agencies in the US is known as a USDMF. Nitroxoline USDMF includes data on Nitroxoline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nitroxoline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nitroxoline suppliers with USDMF on PharmaCompass.
