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