01 1Changzhou SynTheAll Pharmaceutical Co., Ltd
01 1Korea BMS Pharmaceutical Co., Ltd.
01 1Fedratinib hydrochloride hydrate (micronized)
01 1Japan
Fedratinib hydrochloride hydrate (micronized)
Registrant Name : Korea BMS Pharmaceutical Co., Ltd.
Registration Date : 2022-04-27
Registration Number : Su342-18-ND
Manufacturer Name : Changzhou SynTheAll Pharmace...
Manufacturer Address : No. 589 North Yulong Road, Xinbei District Changzhou, CH213127, China
A Fedratinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fedratinib, including repackagers and relabelers. The FDA regulates Fedratinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fedratinib 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 Fedratinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fedratinib supplier is an individual or a company that provides Fedratinib active pharmaceutical ingredient (API) or Fedratinib finished formulations upon request. The Fedratinib suppliers may include Fedratinib API manufacturers, exporters, distributors and traders.
click here to find a list of Fedratinib 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 Fedratinib Drug Master File in Korea (Fedratinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fedratinib. The MFDS reviews the Fedratinib KDMF as part of the drug registration process and uses the information provided in the Fedratinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fedratinib 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 Fedratinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fedratinib suppliers with KDMF on PharmaCompass.
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