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