FutureChem Receives GMP Certification for Production Center at Ewha Womans University Seoul Hospital

[Asia Economy Reporter Hyungsoo Park] FutureChem, a company specializing in radiopharmaceuticals, announced on the 9th that its production center within Ewha Womans University Seoul Hospital has obtained Good Manufacturing Practice (GMP) certification from the Ministry of Food and Drug Safety.

After signing a contract to establish production facilities with Ewha Womans University Seoul Hospital in 2018, the company began investing in the facilities. Until recently, it underwent validation of the suitability and effectiveness of the production equipment to obtain GMP approval.

With GMP certification, FutureChem will officially operate the largest radiopharmaceutical production facility in Korea. Ewha Womans University Seoul Hospital is equipped with a total of 10 state-of-the-art shielding facilities: 8 for production and 2 for dispensing. This is the largest scale among domestic radiopharmaceutical production facilities.

Through mutual cooperation with the Seoul St. Mary’s Hospital production center, products can be stably supplied within Seoul and the metropolitan area. A company official explained, “We expect sales of radiopharmaceuticals such as Alzaview and PDview to increase, especially in the central region.”

FutureChem is also pursuing GMP certification for the production center established by its subsidiary, FutureChem Healthcare, at Kyungpook National University Hospital. The Ewha Womans University Seoul Hospital production center is the fourth GMP-certified facility; FutureChem has obtained GMP certification for Dong-A University Hospital, and FutureChem Healthcare has received certification for Seoul St. Mary’s Hospital and Kosin University Hospital production centers.

A FutureChem official stated, “With the full-scale operation of the Ewha Womans University Seoul Hospital production center, it will also be possible to support the production of research-use pharmaceuticals for clinical trials of the prostate cancer diagnostic drug Prostaview (FC303) and various new drug pipelines.” Additionally, they added, “We expect the speed of clinical development for our main pipelines to accelerate.”