Boryung Pharmaceutical said that its anticancer injection production line at Yesan, South Chungcheong Province, has received good manufacturing practice (GMP) certification from the Ministry of Food and Drug Safety.
With the certification, the company plans to start the production of Velkin, a treatment for multiple myeloma, in earnest, it said. "The anticancer injection production facility has a production scale of at least six million vials per year, and the production volume can be expanded by three times or more if necessary," Boryung said.
The company has also obtained GMP certification to manufacture solid oral drugs in October last year and has been operating a production facility since early this year.
"The anticancer injection production line at Yesan plant has proven its excellence as it obtained certification in a far shorter period than the standard review period," the company said. "The anticancer injection production facility features a state-of-the-art isolator system that can safely produce drugs with high pharmacological activity."
It is also equipped with global-level production systems, such as the advanced GMP management system, the company added.
Boryung said it would prepare to receive EU GMP certification for its anticancer injection production facilities in 2021 and plans to actively promote its anticancer injection in the global market after winning the certification.
These moves come after Boryung Pharmaceutical targeted anticancer drugs as the company's future growth engine and made brisk investments.
"To this end, the company has recently promoted its anticancer business unit to an oncology division and is expanding its product portfolio through acquiring blockbuster drugs and developing new incrementally modified drugs," the company said. "It is also strengthening anticancer drug marketing and sales capabilities as well as while expanding and reinforcing R&D capabilities through open innovation."
The company expects that its anticancer business's growth will be more resilient through the GMP certification of the anticancer drug injection production line, it added.
Boryung Pharmaceutical CEO Lee Sam-soo said, "This GMP certification marks the starting point for further reinforcing the company's production capability along with R&D and marketing in the anticancer drug sector."
Lee added the company plans to increase its production capacity to a global level through EU GMP certification.