01 13D Imaging
01 1[I-124] FIAU (FIALURIDINE)
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24014
Submission : 2010-07-23
Status : Active
Type : II
12
PharmaCompass offers a list of Fialuridine 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 Fialuridine manufacturer or Fialuridine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fialuridine manufacturer or Fialuridine supplier.
A Fialuridine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fialuridine, including repackagers and relabelers. The FDA regulates Fialuridine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fialuridine 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 Fialuridine supplier is an individual or a company that provides Fialuridine active pharmaceutical ingredient (API) or Fialuridine finished formulations upon request. The Fialuridine suppliers may include Fialuridine API manufacturers, exporters, distributors and traders.
click here to find a list of Fialuridine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Fialuridine DMF (Drug Master File) is a document detailing the whole manufacturing process of Fialuridine active pharmaceutical ingredient (API) in detail. Different forms of Fialuridine DMFs exist exist since differing nations have different regulations, such as Fialuridine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fialuridine DMF submitted to regulatory agencies in the US is known as a USDMF. Fialuridine USDMF includes data on Fialuridine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fialuridine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fialuridine suppliers with USDMF on PharmaCompass.
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