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Quasi-drug

What is a bioequivalence testing?

Quasi-drug refers to pharmaceutical goods that are not medicines intended to cure or prevent diseases with less efficacy for human designated by the Ministry of Health and Welfare.

KPTR

provides quality control services for quasi-drugs with its personnel who have experienced such expertise for 20 years. KPTR is the one and only drug quality control institute designated in accordance with law.

According to the Pharmaceutical Affairs Act,

quasi-drugs do not include goods used for medical purposes but covers textile and rubber products used to cure or prevent human and animal diseases which have less efficacy or are not directly applied to human body including the ones that are not equipment, machinery or similar goods along with fungicides and insecticides. Quasi-drugs are subject to reporting to the Minister of Food and Drug Safety for license or registration for each item.

Testing items for quality control

Process requirements of various countries such as KQC, KP and USP, and in-house standards of each company