Olon
Rodano (Milano), Italy
Hybrid — also manufactures internal programs
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (11)
○ Clinical Trials
○ SEC Filings
✓ Press (16)
✓ EMA GMP (44)
○ MHRA GMP
✓ HC GMP (38)
Quick Facts: Olon
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- Rodano (Milano), Italy
- Website
- https://olonspa.com/
- Modalities
- Small Molecule API, Biologics, ADC / Bioconjugation
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Olon
Olon makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Small Molecule API, Biologics, ADC / Bioconjugation. 11 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://olonspa.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Olon FDA Inspection History
2026-01
2025-10
2025-03
2024-05
2023-07
2023-05
2023-03
2023-02
2023-02
2023-02
2021-10
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-01-16 |
Olon SpA
Casaletto Lodigiano
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2025-10-10 |
Olon USA LLC
Concord Township, Ohio
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2025-03-28 |
Olon S.p.A.
Rodano
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2024-05-24 |
Olon SPA
Capua
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2023-07-13 |
Olon SpA
Garbagnate Milanese
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2023-05-04 |
Olon Active Pharmaceutical Ingredients India Private Ltd.
Raigad
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2023-03-03 |
Olon SpA
Segrate
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2023-02-16 |
Olon S.p.A.
Mulazzano
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2023-02-10 |
Olon S.p.A.
Garessio
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2023-02-09 |
Olon S.p.A.
Dorno
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2021-10-01 |
Olon SpA
Settimo Torinese
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Nov 01, 2026
Olon EMA GMP Compliance 44 certificates
2026-01
2026-01
2026-01
2025-11
2025-08
2025-08
2025-04
2025-03
2025-03
2025-01
2025-01
2024-11
2024-10
2024-09
2024-05
2024-05
2023-11
2023-08
2023-07
2023-07
2023-07
2023-06
2023-05
2023-03
2023-03
2023-02
2023-02
2023-02
2022-10
2022-03
2021-07
2020-01
2020-01
2019-10
2019-08
2019-08
2019-07
2019-05
2019-05
2019-05
2019-05
2018-09
2018-09
2018-06
Compliant
Non-Compliant
| Certificate | Site | Country | Inspection Date | Status |
|---|---|---|---|---|
| IT-API/100/H/2026 | Olon S.p.A. | Italy | 2026-01-23 | COMPLIANT |
| IT-API/44/H/2026 | Olon S.p.A. | Italy | 2026-01-16 | COMPLIANT |
| IT-API/85/H/2026 | Olon S.p.A. | Italy | 2026-01-16 | COMPLIANT |
| IT-API/73/H/2026 | Olon S.p.A. | Italy | 2025-11-14 | COMPLIANT |
| IT-API/29/H/2026 | Olon S.p.A. | Italy | 2025-08-01 | COMPLIANT |
| IT-API/58/H/2026 | Olon S.p.A. | Italy | 2025-08-01 | COMPLIANT |
| IT-API/54/H/2026 | Olon S.p.A. | Italy | 2025-04-11 | COMPLIANT |
| IT-API/107/H/2026 | Olon S.p.A. | Italy | 2025-03-28 | COMPLIANT |
| IT-API/119/H/2025 | Olon S.p.A. | Italy | 2025-03-28 | COMPLIANT |
| IT-API/124/H/2025 | Olon S.p.A. | Italy | 2025-01-24 | COMPLIANT |
| IT-API/93/H/2025 | Olon S.p.A. | Italy | 2025-01-24 | COMPLIANT |
| NBF/07/2025/V | Olon S.p.A. | Italy | 2024-11-22 | COMPLIANT |
| IT-API/8/H/2025bis | Olon S.p.A. | Italy | 2024-10-16 | COMPLIANT |
| IT-API/4/H/2025bis | Olon S.p.A. | Italy | 2024-09-27 | COMPLIANT |
| IT-API/190/H/2024 | Olon S.p.A. | Italy | 2024-05-24 | COMPLIANT |
| NBF/59/2024/V | Olon S.p.A. | Italy | 2024-05-24 | COMPLIANT |
| NBF/6/2024/V | Olon S.p.A. | Italy | 2023-11-15 | COMPLIANT |
| IT-API/7/H/2025 | Olon S.p.A. | Italy | 2023-08-31 | COMPLIANT |
| IT-API/27/H/2025 | Olon S.p.A. | Italy | 2023-07-13 | COMPLIANT |
| IT-API/40/H/2024 | Olon S.p.A. | Italy | 2023-07-13 | COMPLIANT |
| IT-API/41/H/2025 | Olon S.p.A. | Italy | 2023-07-13 | COMPLIANT |
| IT-API/182/H/2024 | Olon S.p.A. | Italy | 2023-06-23 | COMPLIANT |
| NBF/04/2025/V | Olon S.p.A. | Italy | 2023-05-31 | COMPLIANT |
| IT-API/14/H/2024 | Olon S.p.A. | Italy | 2023-03-03 | COMPLIANT |
| IT-API/61/H/2025 | Olon S.p.A. | Italy | 2023-03-03 | COMPLIANT |
| IT-API/161/H/2023 | Olon S.p.A. | Italy | 2023-02-16 | COMPLIANT |
| IT-API/12/H/2025bis | Olon S.p.A. | Italy | 2023-02-09 | COMPLIANT |
| IT-API/141/H/2025 | Olon S.p.A. | Italy | 2023-02-09 | COMPLIANT |
| IT-API/295/H/2023 | Olon S.p.A. | Italy | 2022-10-28 | COMPLIANT |
| IT-API/158/H/2023 | Olon S.p.A. | Italy | 2022-03-04 | COMPLIANT |
| NBF/48/2021/V | OLON S.p.A. | Italy | 2021-07-29 | COMPLIANT |
| IT-API/161/H/2020 | Olon S.p.A. | Italy | 2020-01-24 | COMPLIANT |
| IT-API/90/H/2023 | Olon S.p.A. | Italy | 2020-01-24 | COMPLIANT |
| NBF/1/2020/V | OLON S.p.A. | Italy | 2019-10-29 | COMPLIANT |
| IT-API/3/H/2021 | OLON S.P.A. | Italy | 2019-08-09 | COMPLIANT |
| IT-API/44/H/2020 | OLON S.P.A. | Italy | 2019-08-09 | COMPLIANT |
| IT-API/193/H/2019 | OLON S.P.A. | Italy | 2019-07-25 | COMPLIANT |
| IT-API/151/H/2021 | Olon S.p.A. | Italy | 2019-05-24 | COMPLIANT |
| IT-API/157/H/2020 | OLON S.P.A. | Italy | 2019-05-24 | COMPLIANT |
| IT-API/52-/H/2018 | OLON S.P.A. | Italy | 2019-05-24 | COMPLIANT |
| IT-API/79/H/2020 | OLON S.P.A. | Italy | 2019-05-24 | COMPLIANT |
| IT-API/113/H/2021 | OLON S.P.A. | Italy | 2018-09-14 | COMPLIANT |
| IT-API/244/H/2020 | OLON S.P.A. | Italy | 2018-09-14 | COMPLIANT |
| IT-API/129/H/2019 | OLON S.P.A. | Italy | 2018-06-29 | COMPLIANT |
Source: EMA EudraGMDP · Retrieved Nov 01, 2026
Japan-accredited overseas site (PMDA)
general (non-sterile) · 7 sites
- Mahad, India · Olon Active Pharmaceutical Ingredients India Private Limited — general (non-sterile) · valid to May 26, 2029
- Capua, Italy · Olon S.p.A. — general (non-sterile) · valid to May 21, 2027
- Dorno, Italy · Olon S.p.A. — general (non-sterile) · valid to Sep 12, 2027
- Garbagnate Milanese, Italy · Olon S.p.A. — general (non-sterile) · valid to Sep 9, 2027
- Garessio, Italy · Olon S.p.A. — general (non-sterile) · valid to Dec 31, 2029
- Mulazzano, Italy · Olon S.p.A. — general (non-sterile) · valid to Sep 9, 2027
- Italy · Olon S.p.A. — general (non-sterile) · valid to Feb 22, 2027 renewal due
PMDA accreditation of a foreign manufacturing site is recognition within Japan's regulatory system, not an inspection outcome. PMDA's list covers only manufacturing sites outside Japan, so a company's plants in Japan are not on it. Source: PMDA, list of accredited/registered foreign manufacturers (as of Oct 16, 2026), Public Data License 1.0 (terms)
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. This company's careers site asks automated readers not to collect it (robots.txt), and we respect that.
Source:
public careers pages
· Checked Oct 31, 2026
Company Signals 16 articles
Company announcements, not verified evidence. They do not change any score.
Olon S.p.A. Expands Microbial GMP Capabilities at Its Manufacturing Site in Capua - PR Newswire
Italian CDMO buys India API plant that supplies Novartis - Fierce Pharma
Olon Buys Indian API Plant - CHEManager
Olon SpA Acquires Italian CDMO - Contract Pharma
Olon acquires fellow Italian CDMO - The Pharma Letter
Abionyx, Olon Partner to Develop and Commercialize Sepsis Treatment - Contract Pharma
Abionyx, Olon Partner to Develop and Commercialize Sepsis Treatment Contract Pharma
Abionyx Pharma Entrusts Olon with Manufacturing of CER-001 for Market Launch - Idéal Investisseur
Abionyx Pharma Entrusts Olon with Manufacturing of CER-001 for Market Launch Idéal Investisseur
Olon announces the appointment of Roberta Pachera as Vice President of CDMO Small Molecules and Global Key Account Division - Manufacturing Chemist
Olon Group Acquires GTP Bioways - Contract Pharma
Olon Group Announces Two Leadership Appointments - Contract Pharma
Antheia and Olon continue biomanufacturing partnership - Manufacturing Chemist
Olon Group acquires GTP Bioways to expand biotech offering - Manufacturing Chemist
OLON GROUP ANNOUNCES THE ACQUISITION OF GTP BIOWAYS GROUP - DCAT Value Chain Insights
Olon Group Strengthens Its Leadership in Bioproduction with Two Strategic Appointments in France - Koreabizwire
Olon acquires HuvePharma - Speciality Chemicals Magazine
Olon commits to ultra-potent compound manufacturing expansion with new €25m facility - Manufacturing Chemist
Frequently Asked Questions About Olon
How many FDA inspections does Olon have on record?
CDMO Signal tracks 11 FDA inspections for Olon, sourced from the FDA inspection database. See the full inspection history above.
Has Olon received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Olon.
Does Olon hold EMA or MHRA GMP certificates?
CDMO Signal tracks 44 EMA GMP certificates for Olon.
Does Olon have a CDMO Signal Score?
Not yet. Olon is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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