Biocon Biologics
Bengaluru, India
No confirmed program data — ClinicalTrials.gov verification pending
· Last scored 2026-09-07
77.6
Signal Score
✓ FDA Inspections (4)
○ Clinical Trials
○ SEC Filings
✓ Press (3)
✓ EMA GMP (2)
○ MHRA GMP
Quick Facts: Biocon Biologics
- Signal Score
- 77.6/100 (as of 2026-09-07)
- Quality Compliance
- 97.1/100
- Headquarters
- Bengaluru, India
- Modalities
- 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 Biocon Biologics
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
97.1
FDA Inspections4 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-09-03)
EMA GMP Certificates2 on record
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesCell 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
53.0
Profile-based capacity assessment
Recent Press3 articles
Biocon Biologics FDA Inspection History
2025-09
2024-09
2024-09
2024-07
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-09-03 |
Biocon Biologics Limited
Bengaluru
Facility-linked
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2024-09-27 |
Biocon Limited
Bengaluru
Facility-linked
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2024-09-20 |
Biocon Limited
Bangalore
Facility-linked
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2024-07-26 |
Biocon Biologics Limited
Bengaluru
Facility-linked
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 08, 2026
Biocon Biologics EMA GMP Compliance 2 certificates
2026-06
2023-08
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| CRN00H3M2/M13208/00001 | Biocon Biologics Ireland Limited | Ireland | 2026-06-16 | COMPLIANT |
| CRN00H70G/M13208/00001 | Biocon Biologics Ireland Limited | Ireland | 2023-08-01 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Oct 08, 2026
Recent News 3 articles
Biocon Biologics receives 5 procedural observations after US FDA inspection at Bengaluru facility - Indian Pharma Post
Biocon Biologics receives 5 procedural observations after US FDA inspection at Bengaluru facility Indian Pharma Post
India's Biopharma SHAKTI: Syngene, Biocon, Divi's Take Different Routes - Whalesbook
India's Biopharma SHAKTI: Syngene, Biocon, Divi's Take Different Routes Whalesbook
Biopharma SHAKTI: Kya Syngene, Biocon, Divi's ki hogi Qismat Chamki? Sabka Funda Alag! - Whalesbook
Biopharma SHAKTI: Kya Syngene, Biocon, Divi's ki hogi Qismat Chamki? Sabka Funda Alag! Whalesbook
Frequently Asked Questions About Biocon Biologics
How many FDA inspections does Biocon Biologics have on record?
CDMO Signal tracks 4 FDA inspections for Biocon Biologics, sourced from the FDA inspection database. See the full inspection history above.
Has Biocon Biologics received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Biocon Biologics.
Does Biocon Biologics hold EMA or MHRA GMP certificates?
CDMO Signal tracks 2 EMA GMP certificates for Biocon Biologics.
What is Biocon Biologics's CDMO Signal Score?
Biocon Biologics has a Signal Score of 78/100, based on quality, operations, financial stability, and capacity data.
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