In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Stieprox Drug Master File in Korea (Stieprox KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Stieprox. The MFDS reviews the Stieprox KDMF as part of the drug registration process and uses the information provided in the Stieprox KDMF to evaluate the safety and efficacy of the drug.
After submitting a Stieprox 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 Stieprox API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Stieprox suppliers with KDMF on PharmaCompass.