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