Indoco Remedies
Mumbai, India
Hybrid — also manufactures internal programs
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (3)
○ Clinical Trials
○ SEC Filings
✓ Press (3)
○ EMA GMP
✓ MHRA GMP (3)
✓ HC GMP (27)
Quick Facts: Indoco Remedies
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Mumbai, India
- Website
- https://www.indoco.com/
- Modalities
- Small Molecule API, Intermediates, Custom Synthesis, Oral Solid Dose, Topicals
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Indoco Remedies
Indoco Remedies makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Small Molecule API, Intermediates, Custom Synthesis, Oral Solid Dose, Topicals. 3 manufacturing sites registered with the U.S. FDA, the UK MHRA and Health Canada. Website: https://www.indoco.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Indoco Remedies FDA Inspection History
2025-09
2024-05
2023-02
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-09-19 |
Indoco Remedies Limited
Kaire
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2024-05-16 |
Indoco Remedies Limited
Navi Mumbai
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2023-02-28 |
Indoco Remedies Limited
Verna
Company-level
|
Drug Quality Assurance | Yes | Official Action Indicated (OAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Indoco Remedies FDA 483 Findings 4 observations · 2023-02-28 → 2023-02-28 ?
By subsystem
By severity
- 4 — Serious: 2
- 3 — Moderate: 1
- 2 — Minor: 1
- Repeat observations: 0
Most severe findings
-
Environmental Monitoring System
"Aseptic processing areas are deficient regarding the system for monitoring environmental conditions."
-
Equipment to control conditions
"Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions."
-
Scientifically sound laboratory controls
"Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components conform to appropriate standards of identity, strength, quality and purity."
Indoco Remedies MHRA GMP Compliance 3 certificates
2019-05
2018-10
2018-10
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK GMP 19756 Insp GMP 19756/12594-0011[H] | INDOCO REMEDIES LIMITED | IN-403 722 | 2019-05-21 | COMPLIANT |
| UK GMP 19756 Insp GMP 19756/617558-0006 [H] | INDOCO REMEDIES LIMITED | IN-173 205 | 2018-10-18 | COMPLIANT |
| UK GMP 19756 Insp GMP 19756/617558-0006 [V] | INDOCO REMEDIES LIMITED | IN-173 205 | 2018-10-18 | COMPLIANT |
Source: MHRA GMDP Database · 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
Company Signals 3 articles
Company announcements, not verified evidence. They do not change any score.
Earnings call transcript: Indoco Remedies tops INR 500 crore in Q2 2026 - Investing.com UK
Earnings call transcript: Indoco Remedies tops INR 500 crore in Q2 2026 Investing.com UK
Indoco Remedies Shares Slid Even Though It Turned A Profit - Simply Wall Street
Indoco Remedies Shares Slid Even Though It Turned A Profit Simply Wall Street
Indoco Remedies (NSE: INDOCO) Incorporates Warren Lifesciences for Pharmaceutical Manufacturing Activities - Kalkine India
Indoco Remedies (NSE: INDOCO) Incorporates Warren Lifesciences for Pharmaceutical Manufacturing Activities Kalkine India
Frequently Asked Questions About Indoco Remedies
How many FDA inspections does Indoco Remedies have on record?
CDMO Signal tracks 3 FDA inspections for Indoco Remedies, sourced from the FDA inspection database. See the full inspection history above.
Has Indoco Remedies received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Indoco Remedies.
Does Indoco Remedies hold EMA or MHRA GMP certificates?
CDMO Signal tracks 3 MHRA GMP certificates for Indoco Remedies.
Does Indoco Remedies have a CDMO Signal Score?
Not yet. Indoco Remedies is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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