01 1Formosa Laboratories, Inc
01 1Myungmoon Pharmaceutical Co., Ltd.
01 1Tegapur
01 1Taiwan
Registrant Name : Myungmoon Pharmaceutical Co., Ltd.
Registration Date : 2021-03-18
Registration Number : 20210318-211-J-894
Manufacturer Name : Formosa Laboratories, Inc
Manufacturer Address : No. 36 & 36-1 Hoping Street, Louchu Country, Taoyuan 33842, Taiwan
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.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Tegafur Drug Master File in Korea (Tegafur KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tegafur. The MFDS reviews the Tegafur KDMF as part of the drug registration process and uses the information provided in the Tegafur KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tegafur 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 Tegafur API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tegafur suppliers with KDMF on PharmaCompass.
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