Syngene International
Bengaluru, India
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
78.4
Signal Score
✓ FDA Inspections (2)
○ Clinical Trials
○ SEC Filings
✓ Press (9)
○ EMA GMP
○ MHRA GMP
Quick Facts: Syngene International
- Signal Score
- 78.4/100 (as of 2026-04-29)
- Quality Compliance
- 96.1/100
- Headquarters
- Bengaluru, India
- Modalities
- Biologics, Cell Therapy
- Active Programs
- No ClinicalTrials.gov matches confirmed — 1 partnership announcement in press
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CDMO intelligence platform
About Syngene International
Pure-play CDMO.
Signal Score & Pillar Breakdown
Quality Compliance
96.1
FDA Inspections2 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-10-28)
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer. 1 partnership announcement found in press monitoring.
Programs
— no verified data
Sponsors— no verified data
ModalitiesBiologics, Cell Therapy
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: Biocon
Financial assessment: 68.0/100
Source: SEC EDGAR, press monitoring
Profile-based financial assessment
SEC FilingsPrivate company
Parent company: Biocon
Financial assessment: 68.0/100
Capacity
58.0
1 manufacturing site: Bangalore, IN
Modalities: Biologics, Cell Therapy
Capacity assessment: 58.0/100
Sites: Bangalore, IN
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
Recent Press9 articles
1 manufacturing site: Bangalore, IN
Modalities: Biologics, Cell Therapy
Capacity assessment: 58.0/100
Syngene International FDA Inspection History
2025-10
2025-02
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-10-28 | Hauppauge, New York | Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-02-20 | Bengaluru | Drug Quality Assurance | No | No Action Indicated (NAI) |
Source: FDA Data Dashboard · Retrieved Jul 04, 2026
Syngene International FDA 483 Findings 11 observations · 2025-08-21 → 2025-10-28 ?
By subsystem
By severity
- 3 — Moderate: 2
- 2 — Minor: 9
- Repeat observations: 0
Most severe findings
-
Investigations of discrepancies, failures
"There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed."
-
Scientifically sound laboratory controls
"Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity."
-
Cleaning / Sanitizing / Maintenance
"Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product."
Recent News 9 articles
Syngene International Reports Modest 3% FY26 Revenue Growth Amid Biologics Headwinds - IndiaMedToday
Syngene International Reports Modest 3% FY26 Revenue Growth Amid Biologics Headwinds IndiaMedToday
Syngene International Q4 net down 19 pc at Rs 147.9 cr - Devdiscourse
Syngene International Q4 net down 19 pc at Rs 147.9 cr Devdiscourse
Syngene International stock (INE398A01010): Is its CRO model strong enough to unlock new upside for - AD HOC NEWS
Syngene International stock (INE398A01010): Is its CRO model strong enough to unlock new upside for AD HOC NEWS
Syngene International stock (INE398A01010): Is its CRO model strong enough to unlock new upside for - AD HOC NEWS
Syngene International stock (INE398A01010): Is its CRO model strong enough to unlock new upside for AD HOC NEWS
Syngene International stock (INE398A01010): Is its CRO model strong enough to unlock new upside for - AD HOC NEWS
Syngene International stock (INE398A01010): Is its CRO model strong enough to unlock new upside for AD HOC NEWS
Syngene International stock faces headwinds amid contract research slowdown in Q3 FY26 - AD HOC NEWS
Syngene International stock faces headwinds amid contract research slowdown in Q3 FY26 AD HOC NEWS
Syngene International stock faces headwinds amid contract research slowdown in Q3 FY26 - AD HOC NEWS
Syngene International stock faces headwinds amid contract research slowdown in Q3 FY26 AD HOC NEWS
Syngene International Stock (ISIN: INE398A01010) Faces Pressure Amid Biopharma Contract Slowdown - ad-hoc-news.de
Syngene International Stock (ISIN: INE398A01010) Faces Pressure Amid Biopharma Contract Slowdown AD HOC NEWS
VivaMed BioPharma Partners With Syngene International to Advance AI-Derived Repurposed Therapeutic Programs Through Global Validation Infrastructure - BioSpace
VivaMed BioPharma Partners With Syngene International to Advance AI-Derived Repurposed Therapeutic Programs Through Global Validation Infrastructure BioSpace
Frequently Asked Questions About Syngene International
How many FDA inspections does Syngene International have on record?
CDMO Signal tracks 2 FDA inspections for Syngene International, sourced from the FDA inspection database. See the full inspection history above.
Has Syngene International received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Syngene International.
What is Syngene International's CDMO Signal Score?
Syngene International has a Signal Score of 78/100, based on quality, operations, financial stability, and capacity data.
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