01 1Lunan Pharmaceutical
02 3Taiho Pharmaceutical
01 1FTORAFUR (ALSO CALLED FUTRAFUL OR TEGAFUR)
02 2TEGAFUR
03 1UFT CAPSULES (TEGAFUR AND URACIL)
01 1China
02 3Japan
01 1Active
02 3Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36615
Submission : 2021-12-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10400
Submission : 1993-06-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10396
Submission : 1993-06-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4235
Submission : 1981-08-05
Status : Inactive
Type : II
A Tegafur manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tegafur, including repackagers and relabelers. The FDA regulates Tegafur manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tegafur 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 Tegafur manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tegafur supplier is an individual or a company that provides Tegafur active pharmaceutical ingredient (API) or Tegafur finished formulations upon request. The Tegafur suppliers may include Tegafur API manufacturers, exporters, distributors and traders.
click here to find a list of Tegafur suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tegafur DMF (Drug Master File) is a document detailing the whole manufacturing process of Tegafur active pharmaceutical ingredient (API) in detail. Different forms of Tegafur DMFs exist exist since differing nations have different regulations, such as Tegafur USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tegafur DMF submitted to regulatory agencies in the US is known as a USDMF. Tegafur USDMF includes data on Tegafur's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tegafur USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tegafur suppliers with USDMF on PharmaCompass.
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