In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Hycamtin, NSC 609699, Topotecan Hydrochloride Drug Master File in Korea (Hycamtin, NSC 609699, Topotecan Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hycamtin, NSC 609699, Topotecan Hydrochloride. The MFDS reviews the Hycamtin, NSC 609699, Topotecan Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Hycamtin, NSC 609699, Topotecan Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hycamtin, NSC 609699, Topotecan Hydrochloride 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 Hycamtin, NSC 609699, Topotecan Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hycamtin, NSC 609699, Topotecan Hydrochloride suppliers with KDMF on PharmaCompass.