Syngene International

Bengaluru, India
1 partnership announcement in press monitoring · Last scored 2026-09-07
78.5
Signal Score
✓ FDA Inspections (1) ○ Clinical Trials ○ SEC Filings ✓ Press (9) ○ EMA GMP ○ MHRA GMP

Quick Facts: Syngene International

Signal Score
78.5/100 (as of 2026-09-07)
Quality Compliance
96.3/100
Headquarters
Bengaluru, India
Modalities
Biologics, Cell Therapy
Active Programs
Data pending
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

Scores are being republished. Scores are being republished under methodology v3.3. The score shown is the last complete v3.2 result, which is also what directory listings and search results show. A pillar breakdown is not shown because the current one is computed under v3.3 and would not explain a v3.2 score. Regulatory evidence below is current.
Quality Compliance 96.3
FDA Inspections1 on record
Warning Letters0
Last InspectionNo Action Indicated (NAI) (2025-02-20)
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
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability 68.0
Profile-based financial assessment
SEC FilingsPrivate company
Capacity 58.0
Profile-based capacity assessment
Recent Press9 articles

Syngene International FDA Inspection History

2025-02
NAI VAI OAI
Date Site Type Observations Classification
2025-02-20
Syngene International Ltd.
Bengaluru Facility-linked
Drug Quality Assurance No No Action Indicated (NAI)
Source: FDA Data Dashboard · Retrieved Oct 06, 2026
Attribution not established (1)
These records are excluded from this company’s established evidence because their attribution is unresolved. This describes an evidence-linking limitation, not an assessment of the underlying regulatory findings.
Source Establishment named by the regulator Location Identifier
FDA inspection LNK International, Inc. Hauppauge, New York FDA/FEI=2432212
Source records retained verbatim · attribution not established

Recent News 9 articles

regulatory 2026-04-30
Syngene International Reports Modest 3% FY26 Revenue Growth Amid Biologics Headwinds - IndiaMedToday
Syngene International Reports Modest 3% FY26 Revenue Growth Amid Biologics Headwinds  IndiaMedToday
general 2026-04-29
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
general 2026-04-18
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
general 2026-04-18
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
general 2026-04-11
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
regulatory 2026-03-20
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
regulatory 2026-03-20
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
general 2026-03-15
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
partnership 2026-02-19
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 1 FDA inspection 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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