The FDA's due diligence on the domestic manufacturing facilities of Rolontis, a drug that Hanmi exported technology, has entered the final stage. The final process for obtaining final FDA approval has been completed as scheduled. Hanmi's partner Spectrum is rushing to prepare to enter the U.S. market worth about ₩3 trillion in preparation for FDA approval within this year.

According to an industry on the 1st, FDA pre-approval inspection of Hanmi's Pyeongtaek Bio Plant, which produces undiluted liquid of Rolontis (Eflapegrastim), is underway. The schedule, which was scheduled from the end of last month to the beginning of this month, is progressing smoothly.

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