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