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