01 2Avanti Polar Lipids
02 1EASTMAN KODAK
03 1Olon S.p.A
01 1FENRETINIDE
02 1FENRETINIDE LYM-X-SORB(TM) OIL
03 1FENRETINIDE LYM-X-SORB(TM) POWDER
04 1N-(4-HYDROXYPHENYL)-ALL-TRANS-RETINAMIDE(HPR;4-RETINOYLAMINOPHENOL)
01 1Italy
02 3U.S.A
01 3Active
02 1Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18001
Submission : 2005-01-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18000
Submission : 2005-01-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5285
Submission : 1984-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37120
Submission : 2022-05-31
Status : Active
Type : II
A Fenretinide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fenretinide, including repackagers and relabelers. The FDA regulates Fenretinide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fenretinide 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 Fenretinide supplier is an individual or a company that provides Fenretinide active pharmaceutical ingredient (API) or Fenretinide finished formulations upon request. The Fenretinide suppliers may include Fenretinide API manufacturers, exporters, distributors and traders.
click here to find a list of Fenretinide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fenretinide DMF (Drug Master File) is a document detailing the whole manufacturing process of Fenretinide active pharmaceutical ingredient (API) in detail. Different forms of Fenretinide DMFs exist exist since differing nations have different regulations, such as Fenretinide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fenretinide DMF submitted to regulatory agencies in the US is known as a USDMF. Fenretinide USDMF includes data on Fenretinide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fenretinide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fenretinide suppliers with USDMF on PharmaCompass.
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