01 1Ajinomoto Co., Inc.
02 1Organic Synthesis Chemicals Co., Ltd.
01 2Trifluridine
01 2Japan
Registration Number : 302MF10048
Registrant's Address : 1-15-1 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2020-04-17
Latest Date of Registration : 2022-12-07
Registration Number : 225MF10028
Registrant's Address : 3-10-4 Nihonbashi Ningyocho, Chuo-ku, Tokyo
Initial Date of Registration : 2013-02-13
Latest Date of Registration : 2022-10-19
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.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Trifluridine Drug Master File in Japan (Trifluridine JDMF) empowers Trifluridine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Trifluridine JDMF during the approval evaluation for pharmaceutical products. At the time of Trifluridine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Trifluridine suppliers with JDMF on PharmaCompass.
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