Aug 2, 2022

ST PHARM Scores FDA's cGMP Certification (NAI) for Oligo Plant

- 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.

- 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.

- 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.

[News Link]