OneSource Specialty Pharma
India
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (3)
○ Clinical Trials
○ SEC Filings
✓ Press (2)
○ EMA GMP
○ MHRA GMP
✓ HC GMP (3)
Quick Facts: OneSource Specialty Pharma
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- India
- Website
- https://www.onesourcecdmo.com/
- Modalities
- Sterile Fill-Finish, Biologics, Oral Solid Dose
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About OneSource Specialty Pharma
OneSource Specialty Pharma is a contract development and manufacturing organization (CDMO). Capabilities: Sterile Fill-Finish, Biologics, Oral Solid Dose. 2 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://www.onesourcecdmo.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
OneSource Specialty Pharma FDA Inspection History
2026-06
2025-03
2024-03
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-06-30 |
OneSource Specialty Pharma Limited
Bengaluru
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-03-28 |
ONESOURCE SPECIALTY PHARMA LIMITED
Bengaluru
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2024-03-28 |
OneSource Specialty Pharma Limited
Bengaluru
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
OneSource Specialty Pharma FDA 483 Findings 16 observations · 2022-09-01 → 2026-06-30 ?
By subsystem
By severity
- 4 — Serious: 2
- 3 — Moderate: 4
- 2 — Minor: 10
- Repeat observations: 1
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."
-
No written record of investigation
"Written records are not always made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications."
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
Company Signals 2 articles
Company announcements, not verified evidence. They do not change any score.
OneSource Specialty Pharma’s Q2 profit more than doubles on new capacity, volume growth - Moneycontrol.com
OneSource Specialty Pharma’s Q2 profit more than doubles on new capacity, volume growth Moneycontrol.com
OneSource Specialty Pharma announces Q2FY27 results with revenue surge of 37% YoY - Business Upturn
OneSource Specialty Pharma announces Q2FY27 results with revenue surge of 37% YoY Business Upturn
Frequently Asked Questions About OneSource Specialty Pharma
How many FDA inspections does OneSource Specialty Pharma have on record?
CDMO Signal tracks 3 FDA inspections for OneSource Specialty Pharma, sourced from the FDA inspection database. See the full inspection history above.
Has OneSource Specialty Pharma received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for OneSource Specialty Pharma.
Does OneSource Specialty Pharma have a CDMO Signal Score?
Not yet. OneSource Specialty Pharma is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
Evaluating OneSource Specialty Pharma for a manufacturing program?
Use the free AI matchmaker to compare OneSource Specialty Pharma 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
Shilpa Medicare
India (registered sites)
Small Molecule API, Oral Solid Dose, Sterile Fill-Finish, Biologics, Peptides & Oligos
PCI Pharma Services
Bedford, NH, United States · Tredegar, United Kingdom
Sterile Fill-Finish, Biologics, Oral Solid Dose, Clinical Trial Manufacturing, Packaging & Labeling
AbbVie Contract Manufacturing
North Chicago, Illinois, United States
Small Molecule API, High-Potency APIs, Biologics, ADC / Bioconjugation, Sterile Fill-Finish, Lyophilization, Prefilled Syringes, Oral Solid Dose, Hot-Melt Extrusion, Oral Liquids, Topicals
Atabay
Istanbul, Turkey
Small Molecule API, Oral Solid Dose, Sterile Fill-Finish, Biologics
Hanmi Pharm
Seoul, South Korea
Biologics, ADC / Bioconjugation, mRNA/LNP, Prefilled Syringes, Sterile Fill-Finish, Oral Solid Dose
Compare OneSource Specialty Pharma with another CDMO
Side-by-side scoring, FDA inspection history, EMA/MHRA GMP coverage, and clinical-program footprint.