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