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