ST Pharm
Seoul, KR
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
62.6
Signal Score
✓ FDA Inspections (2)
○ Clinical Trials
○ SEC Filings
✓ Press (13)
✓ EMA GMP (4)
○ MHRA GMP
Quick Facts: ST Pharm
- Signal Score
- 62.6/100 (as of 2026-04-29)
- Quality Compliance
- 66.2/100 — OAI classification at Syracuse (2025-08-08) — CRITICAL
- Headquarters
- Seoul, KR
- Modalities
- Oligonucleotide, mRNA
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About ST Pharm
Pure-play CDMO.
Signal Score & Pillar Breakdown
Quality Compliance
66.2
OAI classification at Syracuse (2025-08-08) — CRITICAL
Source: FDA Data Dashboard
OAI classification at Syracuse (2025-08-08) — CRITICAL
FDA Inspections2 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-09-15)
EMA GMP Certificates4 on record
OAI classification at Syracuse (2025-08-08) — CRITICAL
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesOligonucleotide, mRNA
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability
61.0
Private company
Financial assessment: 61.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Private company
Financial assessment: 61.0/100
Capacity
58.0
1 manufacturing site: Seoul, KR
Modalities: Oligonucleotide, mRNA
Capacity assessment: 58.0/100
Sites: Seoul, KR
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
Recent Press13 articles
1 manufacturing site: Seoul, KR
Modalities: Oligonucleotide, mRNA
Capacity assessment: 58.0/100
ST Pharm FDA Inspection History
2025-09
2025-08
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-09-15 | Farmingdale, New York | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-08-08 | Syracuse, New York | Drug Quality Assurance | Yes | Official Action Indicated (OAI) |
Source: FDA Data Dashboard · Retrieved Jul 04, 2026
ST Pharm FDA 483 Findings 10 observations · 2025-08-08 → 2025-09-15 ?
By subsystem
By severity
- 5 — Critical: 1
- 4 — Serious: 1
- 3 — Moderate: 2
- 2 — Minor: 6
- Repeat observations: 0
Most severe findings
-
Written record not kept of program and validation data
"A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes."
-
Validation lacking for sterile drug products
"Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process."
-
Adequate number of batches on stability
"An adequate number of batches of each drug product are not tested nor are records of such data maintained to determine an appropriate expiration date."
ST Pharm EMA GMP Compliance 4 certificates
2026-02
2026-02
2025-09
2025-09
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| sukls529257/2025 | Best Pharm a.s. | Czechia | 2026-02-03 | COMPLIANT |
| sukls529289/2025 | Best Pharm a.s. | Czechia | 2026-02-03 | COMPLIANT |
| DE_HE_01_GMP_2025_0233 | Biotest Pharma GmbH | Germany | 2025-09-29 | COMPLIANT |
| 36512 | West Pharmaceutical Products Ireland Limited | Ireland | 2025-09-12 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Jul 04, 2026
Recent News 13 articles
ST Pharm First-Quarter Operating Profit Surges Tenfold - thelec.net
ST Pharm First-Quarter Operating Profit Surges Tenfold thelec.net
Dong-A group's Q1 sales rise as ST Pharm, Dong-A ST profits climb - koreabiomed.com
Dong-A group's Q1 sales rise as ST Pharm, Dong-A ST profits climb koreabiomed.com
ST Pharm Secures Japanese Patent for Key LNP Material 'STP1244' - 아시아경제
ST Pharm Secures Japanese Patent for Key LNP Material 'STP1244' - The Asia Business Daily 아시아경제
ST Pharm Poised for Order Surge as RNA Therapeutics Market Expands - 서울경제신문
ST Pharm Poised for Order Surge as RNA Therapeutics Market Expands Seoul Economic Daily
ST Pharm Poised for Order Surge as RNA Therapeutics Market Expands - Seoul Economic Daily
ST Pharm Poised for Order Surge as RNA Therapeutics Market Expands Seoul Economic Daily
ST Pharm Signs Record 89.7 Billion Won Oligonucleotide Contract - Businesskorea
ST Pharm Signs Record 89.7 Billion Won Oligonucleotide Contract Businesskorea
ST Pharm lands record-breaking single CMO order worth KRW 89.7 billion from global pharmaceutical giant - 더바이오
ST Pharm lands record-breaking single CMO order worth KRW 89.7 billion from global pharmaceutical giant 더바이오
ST Pharm secures record oligo API deal with European drugmaker - CHOSUNBIZ - Chosunbiz
ST Pharm secures record oligo API deal with European drugmaker - CHOSUNBIZ Chosunbiz
ST Pharm Signs KRW 89.7 Billion Oligonucleotide Order, Largest Single Contract to Date - 아시아경제
ST Pharm Signs KRW 89.7 Billion Oligonucleotide Order, Largest Single Contract to Date 아시아경제
ST Pharm to produce non-clinical samples for Nipah virus mRNA vaccine - koreabiomed.com
ST Pharm to produce non-clinical samples for Nipah virus mRNA vaccine koreabiomed.com
ST Pharm Begins Production of Nipah Virus mRNA Vaccine Samples - 아시아경제
ST Pharm Begins Production of Nipah Virus mRNA Vaccine Samples 아시아경제
ST Pharm begins Nipah mRNA vaccine preclinical production in South Korea - CHOSUNBIZ - Chosunbiz
ST Pharm begins Nipah mRNA vaccine preclinical production in South Korea - CHOSUNBIZ biz.chosun.com
Korea’s pharma ramps up capacity to win global orders amid pricing shifts - CHOSUNBIZ - biz.chosun.com
Korea’s pharma ramps up capacity to win global orders amid pricing shifts - CHOSUNBIZ Chosunbiz
Frequently Asked Questions About ST Pharm
How many FDA inspections does ST Pharm have on record?
CDMO Signal tracks 2 FDA inspections for ST Pharm, sourced from the FDA inspection database. See the full inspection history above.
Has ST Pharm received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for ST Pharm.
Does ST Pharm hold EMA or MHRA GMP certificates?
CDMO Signal tracks 4 EMA GMP certificates for ST Pharm.
What is ST Pharm's CDMO Signal Score?
ST Pharm has a Signal Score of 63/100, based on quality, operations, financial stability, and capacity data.
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