01 1Shanghai SyntheAll Pharmaceutical Co., Ltd
01 1AstraZeneca Korea
01 1Roxadustat
01 1China
Registrant Name : AstraZeneca Korea
Registration Date : 2021-07-09
Registration Number : Su248-16-ND
Manufacturer Name : Shanghai SyntheAll Pharmaceu...
Manufacturer Address : No.9, Yuegong Road, Jinshan District, Shanghai, 201507, China
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PharmaCompass offers a list of Roxadustat API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Roxadustat manufacturer or Roxadustat supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Roxadustat manufacturer or Roxadustat supplier.
A Roxadustat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Roxadustat, including repackagers and relabelers. The FDA regulates Roxadustat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Roxadustat 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 Roxadustat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Roxadustat supplier is an individual or a company that provides Roxadustat active pharmaceutical ingredient (API) or Roxadustat finished formulations upon request. The Roxadustat suppliers may include Roxadustat API manufacturers, exporters, distributors and traders.
click here to find a list of Roxadustat 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 Roxadustat Drug Master File in Korea (Roxadustat KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Roxadustat. The MFDS reviews the Roxadustat KDMF as part of the drug registration process and uses the information provided in the Roxadustat KDMF to evaluate the safety and efficacy of the drug.
After submitting a Roxadustat 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 Roxadustat API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Roxadustat suppliers with KDMF on PharmaCompass.
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