Samsung BioLogics Co., the biopharmaceutical arm of South Korea’s Samsung Group, has won the FDA’s manufacturing approval of medical products from its new second plant, a faster-than-expected result that would boost its entry into the world’s largest pharmaceutical market.
The company said on Thursday the latest regulatory approval is applied to biological agents to be manufactured at its plant in Songdo, Incheon, which has an annual production capacity of 150,000 liters. The company did not specify the drugs due to confidentiality agreements with clients.
The U.S health authorities require manufacturers to register not only their drugs but also manufacturing facilities to produce them before marketing in the U.S. Samsung BioLogics received its first FDA manufacturing approval for products from its first plant in November 2015 and currently holds nine approvals.
The company said the speedy approval would enable it to make an early push in the U.S. biopharmaceutical market. The second plant was given the go-ahead in 19 months, six months faster than the first one, despite more review conditions due to a larger plant size.
Shares of Samsung BioLogics closed Thursday at a record high of 377,500 won ($333), up 8.63 percent or 30,000 won from the previous session.
By Shin Chan-ok
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