ST Pharm announced on Monday it won the U.S. FDA’s current Good Manufacturing Practice (cGMP) certification for its oligonucleotide (oligo) plant in Korea, for the first time in Asia.

An FDA inspection team visited ST Pharm’s oligo factory in Banwol in Ansan in May and conducted a pre-approval inspection (PAI) for around a week, according to the company.

PAI is required before novel drug approval and raw material medicine supply. ST Pharm received a No Action Indicated (NAI) grade which does not require any submission of corrected data because the FDA did not detect any flaws during the inspection.

ST Pharm has been only able to export raw materials of oligonucleotide treatment for clinical trial use to the U.S. so far.

However, the cGMP approval by the U.S. regulator has enabled large-scale exports for commercial use, the company said.

ST Pharm expects four FDA PAIs by the first half of 2023. This means FDA approval for novel drugs that ST Pharm supplies raw materials could be imminent.

The company said that the cGMP approval would bring a positive impact on future inspections and that ST Pharm’s sales would also increase should the novel drugs succeed in commercialization.

An ST Pharm official said, “We anticipate expanding oligo orders as large-scale raw material export to the U.S. has become possible.”

The official expected that ST Pharm’s business such as the mRNA CDMO would gain momentum after the FDA certification.

ST Pharm received the Best Practice Award-Asia-Pacific Oligonucleotide CDMO Company of the Year from a global market research institute, Frost & Sullivan in May.