In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Calaptin 240 SR Drug Master File in Korea (Calaptin 240 SR KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Calaptin 240 SR. The MFDS reviews the Calaptin 240 SR KDMF as part of the drug registration process and uses the information provided in the Calaptin 240 SR KDMF to evaluate the safety and efficacy of the drug.
After submitting a Calaptin 240 SR 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 Calaptin 240 SR API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Calaptin 240 SR suppliers with KDMF on PharmaCompass.