Panacea Biotec
New Delhi, India
Hybrid — also manufactures internal programs
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (2)
○ Clinical Trials
○ SEC Filings
○ Press
○ EMA GMP
○ MHRA GMP
✓ HC GMP (4)
Quick Facts: Panacea Biotec
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- New Delhi, India
- Website
- https://www.panaceabiotec.com/
- Modalities
- Oral Solid Dose, Vaccines, Sterile Injectables
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Panacea Biotec
Panacea Biotec makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Oral Solid Dose, Vaccines, Sterile Injectables. 1 manufacturing site registered with the U.S. FDA and Health Canada. Website: https://www.panaceabiotec.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Panacea Biotec FDA Inspection History
2023-10
2022-06
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2023-10-12 |
Panacea Biotec Pharma Limited
Malpur
Company-level
|
Drug Quality Assurance | Yes | Official Action Indicated (OAI) |
| 2022-06-08 |
Panacea Biotec Pharma Limited
Malpur
Company-level
|
Drug Quality Assurance | No | Official Action Indicated (OAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Panacea Biotec FDA 483 Findings 9 observations · 2023-10-12 → 2023-10-12 ?
By subsystem
By severity
- 4 — Serious: 2
- 3 — Moderate: 2
- 2 — Minor: 5
- Repeat observations: 0
Most severe findings
-
Validation lacking for sterile drug products
"Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process."
-
Environmental Monitoring System
"Aseptic processing areas are deficient regarding the system for monitoring environmental conditions."
-
Scientifically sound laboratory controls
"Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity."
EMA Non-Compliance Statements 1
NNGYK/11120-1/2026 — Panacea Biotec Pharma Limited, India
Issued: 2026-02-03
Issued: 2026-02-03
Source: EMA EudraGMDP · Retrieved Oct 31, 2026
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 Panacea Biotec
How many FDA inspections does Panacea Biotec have on record?
CDMO Signal tracks 2 FDA inspections for Panacea Biotec, sourced from the FDA inspection database. See the full inspection history above.
Has Panacea Biotec received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Panacea Biotec.
Does Panacea Biotec have a CDMO Signal Score?
Not yet. Panacea Biotec is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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