Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Aurobindo Pharma Limited
03 1Intas Pharmaceuticals
04 1MSN Laboratories
05 1Natco Pharma
06 1Taiho Pharmaceutical
07 1Univar Inc
08 2Yuki Gosei Kogyo
09 1Blank
01 13'-DEOXY-3'-[18F] FLUOROTHYMIDINE
02 2TRIFLUOROTHYMIDINE
03 3TRIFLURIDINE
04 1TRIFLURIDINE DRUG SUBSTANCE
05 3TRIFLURIDINE USP
01 5India
02 3Japan
03 1U.S.A
04 1Blank
01 9Active
02 1Inactive
01 5Complete
02 5Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33065
Submission : 2018-09-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-05
Pay. Date : 2019-05-23
DMF Number : 33880
Submission : 2019-05-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-03
Pay. Date : 2019-02-20
DMF Number : 33615
Submission : 2019-03-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-24
Pay. Date : 2019-04-15
DMF Number : 33573
Submission : 2019-02-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-25
Pay. Date : 2019-07-25
DMF Number : 33925
Submission : 2019-08-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34596
Submission : 2020-03-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29297
Submission : 2015-04-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28479
Submission : 2014-11-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-12-05
Pay. Date : 2013-04-03
DMF Number : 12010
Submission : 1996-06-20
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2427
Submission : 1975-03-19
Status : Inactive
Type : II
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A Trifluridine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trifluridine, including repackagers and relabelers. The FDA regulates Trifluridine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trifluridine 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 Trifluridine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trifluridine supplier is an individual or a company that provides Trifluridine active pharmaceutical ingredient (API) or Trifluridine finished formulations upon request. The Trifluridine suppliers may include Trifluridine API manufacturers, exporters, distributors and traders.
click here to find a list of Trifluridine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trifluridine DMF (Drug Master File) is a document detailing the whole manufacturing process of Trifluridine active pharmaceutical ingredient (API) in detail. Different forms of Trifluridine DMFs exist exist since differing nations have different regulations, such as Trifluridine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trifluridine DMF submitted to regulatory agencies in the US is known as a USDMF. Trifluridine USDMF includes data on Trifluridine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trifluridine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trifluridine suppliers with USDMF on PharmaCompass.
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