Gland Pharma
Hyderabad, India · Visakhapatnam, India · France · Belgium
Hybrid — also manufactures internal programs
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (9)
○ Clinical Trials
○ SEC Filings
✓ Press (11)
✓ EMA GMP (9)
✓ MHRA GMP (2)
✓ HC GMP (55)
Quick Facts: Gland Pharma
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Hyderabad, India · Visakhapatnam, India · France · Belgium
- Website
- https://www.glandpharma.com/
- Modalities
- Sterile Fill-Finish, Sterile Injectables, Small Molecule API
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Gland Pharma
Gland Pharma makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Sterile Fill-Finish, Sterile Injectables, Small Molecule API. 8 manufacturing sites registered with the U.S. FDA, Health Canada and the UK MHRA, including the Cenexi plants in France and Belgium. Website: https://www.glandpharma.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Gland Pharma FDA Inspection History
2024-07
2024-05
2024-03
2023-07
2023-07
2023-06
2023-01
2022-12
2022-10
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2024-07-25 |
Gland Pharma Limited
Hyderabad
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2024-05-24 |
Gland Pharma Limited
Parawada, Anakapalli
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2024-03-01 |
Cenexi HSC
Herouville St Clair
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2023-07-28 |
Gland Pharma Limited
Visakhapatnam
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2023-07-14 |
Gland Pharma Limited
Hyderabad
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2023-06-27 |
Gland Pharma Limited
Sangareddy district, Hyderabad
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2023-01-27 |
Gland Pharma Limited
Parawada, Anakapalli
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2022-12-14 |
Cenexi
Osny
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2022-10-26 |
Cenexi
Fontenay-Sous-Bois
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Oct 31, 2026
Gland Pharma FDA 483 Findings 6 observations · 2022-08-25 → 2024-07-25 ?
By subsystem
By severity
- 3 — Moderate: 1
- 2 — Minor: 5
- Repeat observations: 0
Most severe findings
-
Complete test data included in records
"Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards."
-
Record maintenance 1 year (except exempt OTC)
"All records of production and control associated with a batch of drug product were not maintained at least one (1) year after the expiration date."
-
Procedures not in writing, fully followed
"The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed."
Gland Pharma EMA GMP Compliance 9 certificates
2024-12
2024-12
2024-05
2024-05
2022-12
2022-12
2022-12
2022-12
2022-10
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| 2025_HPF_FR_059 | Cenexi | France | 2024-12-19 | COMPLIANT |
| 2025_HPF_FR_060 | Cenexi | France | 2024-12-19 | COMPLIANT |
| 2024_HPF_FR_080 | Cenexi HSC | France | 2024-05-17 | COMPLIANT |
| 2024_HPF_FR_081 | Cenexi HSC | France | 2024-05-17 | COMPLIANT |
| 2023_HPF_FR_060 | Cenexi | France | 2022-12-14 | COMPLIANT |
| 2023_HPF_FR_060_P_2025 | Cenexi | France | 2022-12-14 | COMPLIANT |
| 2023_HPF_FR_061 | Cenexi | France | 2022-12-14 | COMPLIANT |
| 2023_HPF_FR_061_P_2025 | Cenexi | France | 2022-12-14 | COMPLIANT |
| 24/350775 | Cenexi | France | 2022-10-26 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Oct 31, 2026
Gland Pharma MHRA GMP Compliance 2 certificates
2024-06
2023-11
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK GMP 39716 Insp GMP 39716/3187772-0007[H] | GLAND PHARMA LIMITED | IN-500 043 | 2024-06-17 | COMPLIANT |
| UK GMP 39716 Insp GMP 39716/31991822-0001[H] | GLAND PHARMA LIMITED | IN-502307 | 2023-11-20 | 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 11 articles
Company announcements, not verified evidence. They do not change any score.
Gland Pharma (NSEI:GLAND) Stock Price - Simply Wall Street
Gland Pharma (NSEI:GLAND) Stock Price Simply Wall Street
Gland Pharma 'Buy' retained by Nomura, target price raised to Rs3,750 on CDMO-led strategic reset - TradingView
Gland Pharma 'Buy' retained by Nomura, target price raised to Rs3,750 on CDMO-led strategic reset TradingView
Why Gland Pharma, Gujarat Energy, other stocks are making headlines - Zee Business
Why Gland Pharma, Gujarat Energy, other stocks are making headlines Zee Business
Gland Pharma to buy French pharma company Cenexi - Indian Pharma Post
Gland Pharma Limited Strong Q4 FY26 Results with 22% Revenue Growth - InvestyWise
Gland Pharma, Neuland enter into long-term sterile API CDMO partnership - The Times of India
Gland Pharma, Neuland Laboratories Partner for Sterile API Manufacturing Suite - scanx.trade
Gland Pharma signs pact with Neuland Labs - The Hans India
Neuland Labs Partners Gland Pharma for Sterile API Expansion - InvestyWise
Gland Pharma, Neuland Announce Strategic CDMO Partnership for Complex Sterile APIs - Medical Dialogues
Gland Pharma and Neuland Laboratories Announce Strategic Collaboration for Sterile API Manufacturing - India Education Diary
Frequently Asked Questions About Gland Pharma
How many FDA inspections does Gland Pharma have on record?
CDMO Signal tracks 9 FDA inspections for Gland Pharma, sourced from the FDA inspection database. See the full inspection history above.
Has Gland Pharma received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Gland Pharma.
Does Gland Pharma hold EMA or MHRA GMP certificates?
CDMO Signal tracks 9 EMA and 2 MHRA GMP certificates for Gland Pharma.
Does Gland Pharma have a CDMO Signal Score?
Not yet. Gland Pharma is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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