ST Pharm’s Banwol facility passes FDA inspection, eyes drug breakthroughs

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ST Pharm’s Banwol facility passes FDA inspection, eyes drug breakthroughs

Published: 06 Nov. 2023, 09:32

ST Pharm’s Banwol facility [DONG-A SOCIO HOLDINGS]

ST Pharm’s Oligo production facility in Banwol has passed a regular inspection by the U.S. Food and Drug Administration (FDA) for cGMP (Current Good Manufacturing Practice).

With this approval, ST Pharm has been recognized as having manufacturing facility capable of stably producing and supplying high-quality Oligo by meeting global pharmaceutical manufacturing and quality standards.

ST Pharm has also become the first contract development and manufacturing organization (CDMO) company in Asia to receive FDA certification for both small molecular drugs and Oligo nucleic acid treatment raw materials, demonstrating its global competitiveness.

Small molecular drugs are any organic compound with low molecular weight. Oligo, which typically refers to oligonucleotides, play a crucial role in genetics and genomics research, diagnostics and therapeutics.

Meanwhile, ST Pharm’s Banwol facility has been continuously investing to enhance its Oligo production capacity.

Upon completion of the second Oligo facility unit — following the first one in 2018 — the company’s Oligo production capacity is expected to increase to a maximum of 14mols (molecules) of output by 2026, marking the world's leading Oligo production capacity.

Especially in the coming year, ST Pharm has promising new drugs in the pipeline, targeting blood cancer and cardiovascular disease using Oligo nucleic acid.

With multiple FDA Pre Approval Inspections (PAI) scheduled, the recent successful inspection of the production facility is expected to be a positive indicator.

"With the ability to supply raw materials on a large scale to advanced markets like the United States, we anticipate revenue expansion. After next year's FDA PAI inspections and more, ST Pharm 's Oligo projects and CDMO business are expected to gain even more momentum,” an ST Pharm official said.

BY KIM SU-HYEON [kim.suhyeon4@joongang.co.kr]