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