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