Concord Biotech
India
Hybrid — also manufactures internal programs
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (3)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
○ MHRA GMP
✓ HC GMP (11)
Quick Facts: Concord Biotech
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- India
- Website
- https://concordbiotech.com/
- Modalities
- Small Molecule API
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Concord Biotech
Concord Biotech makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Small Molecule API. 2 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://concordbiotech.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Concord Biotech FDA Inspection History
2025-05
2023-06
2023-03
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-05-02 |
Concord Biotech Limited
Ahmedabad, Gujarat State
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2023-06-30 |
CONCORD BIOTECH LIMITED
Kheda
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2023-03-17 |
CONCORD BIOTECH LIMITED
Ahmedabad
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Concord Biotech FDA 483 Findings 2 observations · 2023-03-17 → 2023-03-17 ?
By subsystem
By severity
- 3 — Moderate: 1
- 2 — Minor: 1
- 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."
-
Procedures not in writing, fully followed
"The responsibilities and procedures applicable to the quality control unit are not fully followed."
Hiring Activity Beta
Built from public job postings when a company's own roles can be read. Job postings are signals, not statements by the company; each one below links to the original. How we collect this
No hiring data yet. We haven't found a public jobs feed for this company.
Source:
public careers pages
· Checked Oct 30, 2026
Frequently Asked Questions About Concord Biotech
How many FDA inspections does Concord Biotech have on record?
CDMO Signal tracks 3 FDA inspections for Concord Biotech, sourced from the FDA inspection database. See the full inspection history above.
Has Concord Biotech received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Concord Biotech.
Does Concord Biotech have a CDMO Signal Score?
Not yet. Concord Biotech is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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