01 1PVP Sociedade Anonima
01 1QUERCETIN
01 1Brazil
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10633
Submission : 1993-11-09
Status : Inactive
Type : II
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A Xanthaurine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Xanthaurine, including repackagers and relabelers. The FDA regulates Xanthaurine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Xanthaurine 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 Xanthaurine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Xanthaurine supplier is an individual or a company that provides Xanthaurine active pharmaceutical ingredient (API) or Xanthaurine finished formulations upon request. The Xanthaurine suppliers may include Xanthaurine API manufacturers, exporters, distributors and traders.
click here to find a list of Xanthaurine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Xanthaurine DMF (Drug Master File) is a document detailing the whole manufacturing process of Xanthaurine active pharmaceutical ingredient (API) in detail. Different forms of Xanthaurine DMFs exist exist since differing nations have different regulations, such as Xanthaurine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Xanthaurine DMF submitted to regulatory agencies in the US is known as a USDMF. Xanthaurine USDMF includes data on Xanthaurine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Xanthaurine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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