- ST Pharm 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.
- 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.