01 1Actylis
02 1Calyx Chemicals & Pharmaceuticals Limited
03 1F. Hoffmann-La Roche
04 1Laurus Labs
05 1Maithri Drugs
06 1Nantong Jinghua Pharmaceutical
07 1Solara Active Pharma Sciences
08 1Viatris
01 15-FLUOROCYTOSINE (FLUCYTOSINE) USP
02 2FLUCYTOSINE
03 1FLUCYTOSINE CAPSULES AND MATCHING PLACEBO
04 3FLUCYTOSINE USP
05 1FLUCYTOSINE, USP
01 1China
02 4India
03 1Switzerland
04 2U.S.A
01 6Active
02 2Inactive
01 5Complete
02 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15476
Submission : 2001-06-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23503
Submission : 2010-01-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9259
Submission : 1991-07-25
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-05
Pay. Date : 2022-11-09
DMF Number : 37631
Submission : 2022-11-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-24
Pay. Date : 2022-07-13
DMF Number : 31959
Submission : 2017-08-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-05
Pay. Date : 2015-02-04
DMF Number : 25094
Submission : 2011-07-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-13
Pay. Date : 2018-07-20
DMF Number : 32090
Submission : 2017-11-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-28
Pay. Date : 2014-06-15
DMF Number : 28247
Submission : 2014-06-16
Status : Active
Type : II
A Flucytosine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Flucytosine, including repackagers and relabelers. The FDA regulates Flucytosine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Flucytosine 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 Flucytosine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Flucytosine supplier is an individual or a company that provides Flucytosine active pharmaceutical ingredient (API) or Flucytosine finished formulations upon request. The Flucytosine suppliers may include Flucytosine API manufacturers, exporters, distributors and traders.
click here to find a list of Flucytosine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Flucytosine DMF (Drug Master File) is a document detailing the whole manufacturing process of Flucytosine active pharmaceutical ingredient (API) in detail. Different forms of Flucytosine DMFs exist exist since differing nations have different regulations, such as Flucytosine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Flucytosine DMF submitted to regulatory agencies in the US is known as a USDMF. Flucytosine USDMF includes data on Flucytosine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Flucytosine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Flucytosine suppliers with USDMF on PharmaCompass.
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