Biocon Biologics
Bangalore, India
Program data pending ClinicalTrials.gov matching
· Last scored 2026-04-29
77.5
Signal Score
✓ FDA Inspections (4)
○ Clinical Trials
○ SEC Filings
✓ Press (3)
✓ EMA GMP (1)
○ MHRA GMP
Quick Facts: Biocon Biologics
- Signal Score
- 77.5/100 (as of 2026-04-29)
- Quality Compliance
- 95.3/100
- Headquarters
- Bangalore, India
- Modalities
- Cell Therapy
- 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 Biocon Biologics
Pure-play CDMO.
Signal Score & Pillar Breakdown
Quality Compliance
95.3
FDA Inspections4 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-09-03)
EMA GMP Certificates1 on record
Operations
—
No ClinicalTrials.gov facility matches confirmed for this manufacturer.
Programs
— no verified data
Sponsors— no verified data
ModalitiesCell 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.
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
56.0
Regulatory milestones (2 articles)
Sites: Bangalore, IN
Source: SEC EDGAR, press monitoring, company profiles
1 manufacturing site
Recent Press3 articles
Regulatory milestones (2 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 | Bengaluru | Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2024-09-27 | Bengaluru | Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2024-09-20 | Bangalore | Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2024-07-26 | Bengaluru | Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Jul 04, 2026
Biocon Biologics EMA GMP Compliance 1 certificates
2023-08
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| CRN00H70G/M13208/00001 | Biocon Biologics Ireland Limited | Ireland | 2023-08-01 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Jul 04, 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 1 EMA GMP certificate 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.
Evaluating Biocon Biologics for a manufacturing program?
Use the free AI matchmaker to compare Biocon Biologics against other CDMOs by FDA, EMA, and clinical-trial data — no login required.
Find & compare CDMOs →
Represent this organization? Contact us to verify or update this profile.
See all CDMOs in:
Similar CDMOs
Syngene International
Bengaluru, India
Signal Score: 79.7
Biologics, Cell Therapy
Kemwell Biopharma
Bengaluru, India
Monoclonal Antibody, Bispecific Antibody, Recombinant Protein, Biosimilars, Cell Therapy, Sterile Fill-Finish
Kemwell Biopharma, Bangalore
Bengaluru, India
Monoclonal Antibody, Bispecific Antibody, Recombinant Protein, Biosimilars, Cell Therapy, Sterile Fill-Finish, Lyophilized Drug Product
Charles River Laboratories
Newbury Park, CA · Memphis, TN · Keele, UK · Rockville, MD
Signal Score: 91.7
CAR-T, Cell Therapy, Gene Editing, Plasmid, AAV, Lentiviral, ADC
Bristol Myers Squibb (CGT Mfg)
Bothell, WA · Warren, NJ
Signal Score: 90.8
CAR-T, Cell Therapy