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01 1Fermion Oy
01 1Bayer Korea Ltd.
01 1Darorutamide
01 1Finland
Registrant Name : Bayer Korea Ltd.
Registration Date : 2020-05-27
Registration Number : Su212-7-ND
Manufacturer Name : Fermion Oy
Manufacturer Address : Orioninkatu 2, Hanko FI-10900 Finland
A Darolutamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Darolutamide, including repackagers and relabelers. The FDA regulates Darolutamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Darolutamide 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 Darolutamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Darolutamide supplier is an individual or a company that provides Darolutamide active pharmaceutical ingredient (API) or Darolutamide finished formulations upon request. The Darolutamide suppliers may include Darolutamide API manufacturers, exporters, distributors and traders.
click here to find a list of Darolutamide 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 Darolutamide Drug Master File in Korea (Darolutamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Darolutamide. The MFDS reviews the Darolutamide KDMF as part of the drug registration process and uses the information provided in the Darolutamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Darolutamide 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 Darolutamide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Darolutamide suppliers with KDMF on PharmaCompass.
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