Lotte Biologics
Incheon, KR · Syracuse, NY
Program data pending ClinicalTrials.gov matching
· Last scored 2026-03-15
65.5
Signal Score
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
✓ Press (12)
Quick Facts: Lotte Biologics
- Signal Score
- 65.5/100 (as of 2026-03-15)
- Quality Compliance
- Assessment pending
- Headquarters
- Incheon, KR · Syracuse, NY
- Modalities
- Biologics, AAV
- Active CGT Programs
- No ClinicalTrials.gov matches confirmed — 6 partnership announcements in press
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CGT manufacturing intelligence platform
Signal Score & Pillar Breakdown
Quality Compliance
—
No FDA inspection records found. This CDMO may operate under a different legal name or may not have US FDA-inspected facilities.
FDA Inspections1 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2024-09-19)
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer. 6 partnership announcements found in press monitoring.
Programs
— no verified data
Sponsors— no verified data
ModalitiesBiologics, AAV
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.
Partnership Announcements (from press monitoring)
Financial Stability
68.0
Parent company: Lotte Group
Financial assessment: 68.0/100
Source: SEC EDGAR, press monitoring
Subsidiary of Lotte Group
SEC FilingsParent: Lotte Group
Parent company: Lotte Group
Financial assessment: 68.0/100
Capacity
63.0
2 CGT manufacturing sites
Strong partnership activity (6 articles)
Sites: Incheon, South Korea, Syracuse, NY
Source: SEC EDGAR, press monitoring, company profiles
2 CGT manufacturing sites
Recent Press12 articles
2 CGT manufacturing sites
Strong partnership activity (6 articles)
FDA Inspection History
2024-09
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2024-09-19 | East Syracuse, New York | Drug Quality Assurance | No | No Action Indicated (NAI) |
Source: FDA Data Dashboard · Retrieved Mar 20, 2026
Recent News 12 articles
LOTTE Biologics Implements ValGenesis e-Logbook Solution to Modernize QC Operations - BioSpace
LOTTE Biologics Implements ValGenesis e-Logbook Solution to Modernize QC Operations BioSpace
Lotte Biologics boosts talent, builds Songdo plant, confronts Korea dual-listing risk - CHOSUNBIZ - Chosunbiz
Lotte Biologics boosts talent, builds Songdo plant, confronts Korea dual-listing risk - CHOSUNBIZ Chosunbiz
LOTTE Biologics Implements ValGenesis e-Logbook Solution to Modernize QC Operations - Business Wire
LOTTE Biologics Implements ValGenesis e-Logbook Solution to Modernize QC Operations Business Wire
LOTTE Biologics to Participate in DCAT Week 2026 in New York to Explore Global Partnership Opportunities - ANTARA News
LOTTE Biologics to Participate in DCAT Week 2026 in New York to Explore Global Partnership Opportunities ANTARA News
Lotte Biologics seeks global partnerships at DCAT Week - The Korea Herald
Lotte Biologics seeks global partnerships at DCAT Week The Korea Herald
Lotte Biologics to seek CDMO partnerships at DCAT Week 2026 - koreabiomed.com
Lotte Biologics to seek CDMO partnerships at DCAT Week 2026 koreabiomed.com
LOTTE Biologics to Participate in DCAT Week 2026 in New York to Explore Global Partnership Opportunities - ANI News
LOTTE Biologics to Participate in DCAT Week 2026 in New York to Explore Global Partnership Opportunities ANI News
LOTTE Biologics to Participate in DCAT Week 2026 in New York to Explore Global Partnership Opportunities - PR Newswire
LOTTE Biologics to Participate in DCAT Week 2026 in New York to Explore Global Partnership Opportunities PR Newswire
Shin Yoo-yeol steps into spotlight as Lotte’s biotech bet tests heir - The Korea Herald
Shin Yoo-yeol steps into spotlight as Lotte’s biotech bet tests heir The Korea Herald
Lotte Biologics aims to overcome the limitations of latecomers in the biopharmaceutical commissioned.. - 매일경제
Lotte Biologics aims to overcome the limitations of latecomers in the biopharmaceutical commissioned.. 매일경제
LOTTE BIOLOGICS Signs Strategic Partnership Agreement With U.S.-Based Asimov - Bioprocess Online
LOTTE BIOLOGICS Signs Strategic Partnership Agreement With U.S.-Based Asimov Bioprocess Online
Lotte Biologics Bets Drugmakers Will Shift Orders Out of China - Bloomberg.com
Lotte Biologics Bets Drugmakers Will Shift Orders Out of China Bloomberg.com
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