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