01 1Taiho Pharmaceutical Co., Ltd. Saitama Plant
01 1Synex Co., Ltd.
01 1Tipiracil hydrochloride
01 1Japan
Registrant Name : Synex Co., Ltd.
Registration Date : 2018-12-26
Registration Number : Su487-2-ND
Manufacturer Name : Taiho Pharmaceutical Co., Lt...
Manufacturer Address : 200-22 Motohara, Kamikawa-machi, Kodama-gun, Saitama 367-0241, Japan
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A TAS-1-462 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TAS-1-462, including repackagers and relabelers. The FDA regulates TAS-1-462 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TAS-1-462 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 TAS-1-462 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A TAS-1-462 supplier is an individual or a company that provides TAS-1-462 active pharmaceutical ingredient (API) or TAS-1-462 finished formulations upon request. The TAS-1-462 suppliers may include TAS-1-462 API manufacturers, exporters, distributors and traders.
click here to find a list of TAS-1-462 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a TAS-1-462 Drug Master File in Korea (TAS-1-462 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of TAS-1-462. The MFDS reviews the TAS-1-462 KDMF as part of the drug registration process and uses the information provided in the TAS-1-462 KDMF to evaluate the safety and efficacy of the drug.
After submitting a TAS-1-462 KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their TAS-1-462 API can apply through the Korea Drug Master File (KDMF).
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