01 1Shionogi Pharma Co., Ltd. (Tokushima Plant)
01 1Roche Korea Co., Ltd.
01 1Baloxavir marboxil
01 1Japan
Registrant Name : Roche Korea Co., Ltd.
Registration Date : 2019-11-22
Registration Number : Su188-4-ND
Manufacturer Name : Shionogi Pharma Co., Ltd. (T...
Manufacturer Address : 224-20, Hiraishiebisuno, Kawauchi-cho, Tokushima Tokushima 771-0132, Japan
A Baloxavir Marboxil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Baloxavir Marboxil, including repackagers and relabelers. The FDA regulates Baloxavir Marboxil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Baloxavir Marboxil 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 Baloxavir Marboxil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Baloxavir Marboxil supplier is an individual or a company that provides Baloxavir Marboxil active pharmaceutical ingredient (API) or Baloxavir Marboxil finished formulations upon request. The Baloxavir Marboxil suppliers may include Baloxavir Marboxil API manufacturers, exporters, distributors and traders.
click here to find a list of Baloxavir Marboxil 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 Baloxavir Marboxil Drug Master File in Korea (Baloxavir Marboxil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Baloxavir Marboxil. The MFDS reviews the Baloxavir Marboxil KDMF as part of the drug registration process and uses the information provided in the Baloxavir Marboxil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Baloxavir Marboxil 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 Baloxavir Marboxil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Baloxavir Marboxil suppliers with KDMF on PharmaCompass.
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