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