U.S. President Donald Trump has announced plans to impose tariffs on pharmaceuticals, and SK Biopharm, which sells the epilepsy drug 'cenobamate' (known in the U.S. as Xcopri), emphasized that it has already prepared various countermeasures, including securing contract manufacturing organization (CMO) facilities in the U.S.
SK Biopharm noted on the 21st that it has been preparing response strategies including the transfer of production technology and securing local inventory to ensure stable pharmaceutical supply amid a rapidly changing policy environment and supply chain uncertainties.
Currently, cenobamate sold in the U.S. is exported after producing active pharmaceutical ingredients (API) in Korea and undergoing tablet processing and packaging in Canada. The company preemptively prepared to add and transfer production facilities, complete the transfer of cenobamate production technology and process validation, and received approval from the U.S. Food and Drug Administration (FDA) in the second half of last year.
SK Biopharm also has secured FDA-approved CMO facilities in the U.S. They plan to respond flexibly and swiftly to changes in tariff policies through this.
The company has secured approximately six months' worth of inventory in the U.S. that can be utilized while responding to tariff changes. It is also reviewing additional production sites beyond the already secured CMO partners in the U.S. and Canada.
An SK Biopharm official said, 'Maintaining the outsourcing production method through CMO allows for more flexible and rapid responses than direct production,' adding, 'Since over 70% of total expenses are already incurred in the U.S., the company's tariff countermeasures are expected to be feasible.'