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