01 1Actylis
02 1DALIAN ZHEN AO BIO TECH CO LTD
03 1SIGMA TAU
04 1The Division of Cancer Treatment and Diagnosis
01 13-O-LAUROYL-L-CARNITINE HYDROCHLORIDE (LLC) PRECLINICAL AND CLINICAL DATA
02 1URIDINE
03 1URIDINE 5' -MONOPHOSPHATE DISODIUM SALT
04 1URIDINE PRODUCT #3401
01 1China
02 3U.S.A
01 4Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4568
Submission : 1982-04-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23211
Submission : 2009-10-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3349
Submission : 1978-10-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5272
Submission : 1984-03-02
Status : Inactive
Type : II
A Uridine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Uridine, including repackagers and relabelers. The FDA regulates Uridine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Uridine 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 Uridine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Uridine supplier is an individual or a company that provides Uridine active pharmaceutical ingredient (API) or Uridine finished formulations upon request. The Uridine suppliers may include Uridine API manufacturers, exporters, distributors and traders.
click here to find a list of Uridine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Uridine DMF (Drug Master File) is a document detailing the whole manufacturing process of Uridine active pharmaceutical ingredient (API) in detail. Different forms of Uridine DMFs exist exist since differing nations have different regulations, such as Uridine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Uridine DMF submitted to regulatory agencies in the US is known as a USDMF. Uridine USDMF includes data on Uridine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Uridine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Uridine suppliers with USDMF on PharmaCompass.
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