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