BioInfra

Bioequivalence studies for generics (fasting and fed, including designs for highly variable drugs), clinical PK studies for incrementally modified drugs, drug-interaction, food-effect and comparative PK studies, plus IRB submission, medical writing and clinical operations.

Method development and validation and PK sample analysis under MFDS, OECD and FDA GLP/GCLP standards; passed a WHO pre-qualification audit in 2012 and was certified as a KGCLP facility in 2018.

Testing of genotoxic impurities such as nitrosamines and of elemental impurities in drug substances and drug products, from method development to analysis; the work has been run by U&Infra, a joint venture set up with Yuan Life Sciences in 2021.

Head office on the fourth and fifth floors of Heungdeok U-Tower, Giheung-gu, Yongin, Gyeonggi-do, with a branch in Yeoksam, Gangnam-gu, Seoul.

Reported preliminary Q2 2026 results: revenue of KRW 8.662 billion (up 43% year on year), operating profit of KRW 227 million and net income of KRW 152 million, both turning positive.

Agreed to buy the remaining shares of its joint venture U&Infra, making it a wholly owned subsidiary and bringing genotoxic impurity testing in-house.

The board approved a no-new-share absorption merger of wholly owned subsidiary U&Infra, with a merger date of 17 November 2026.