ACS Dobfar

Italy
Hybrid — also manufactures internal programs
Small Molecule API Sterile Fill-Finish
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (7) ○ Clinical Trials ○ SEC Filings ○ Press ✓ EMA GMP (31) ○ MHRA GMP ✓ HC GMP (38)

Quick Facts: ACS Dobfar

Signal Score
Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
Headquarters
Italy
Website
Modalities
Small Molecule API, Sterile Fill-Finish
Active Programs
No ClinicalTrials.gov matches confirmed
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring

About ACS Dobfar

ACS Dobfar makes its own pharmaceutical products and also offers contract development and manufacturing services. Capabilities: Small Molecule API, Sterile Fill-Finish. 7 manufacturing sites registered with the U.S. FDA and Health Canada. Website: https://www.acsdobfar.it/

Signal Score

Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works

ACS Dobfar FDA Inspection History

2024-12
2024-10
2023-11
2023-10
2022-10
2022-09
2022-04
NAI VAI OAI
Date Site Type Observations Classification
2024-12-13
ACS Dobfar S.p.A.
Teramo, San Nicolo A Tordino Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
2024-10-16
ACS Dobfar SpA
Castellalto Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
2023-11-23
ACS Dobfar SPA
Tribiano Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
2023-10-27
ACS Dobfar S.p.A.
Verona Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
2022-10-14
ACS Dobfar S.p.A.
Anagni Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
2022-09-23
ACS Dobfar SpA
Albano Sant'Alessandro Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
2022-04-08
ACS Dobfar S.p.A.
Teramo, San Nicolo A Tordino Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Oct 31, 2026

ACS Dobfar EMA GMP Compliance 31 certificates

2026-04
2026-03
2026-01
2025-05
2024-12
2024-10
2024-10
2024-05
2024-04
2024-03
2024-03
2023-12
2023-11
2023-11
2023-05
2022-10
2022-09
2021-07
2021-07
2020-01
2020-01
2019-12
2019-12
2019-07
2019-03
2019-03
2019-03
2019-03
2018-12
2018-10
2018-10
Compliant Non-Compliant
Certificate Site Country Inspection Date Status
IT-API/114/H/2026 Acs Dobfar S.p.A. Italy 2026-04-16 COMPLIANT
IT/155/H/2026 Acs Dobfar S.p.A. Italy 2026-03-27 COMPLIANT
IT-API/62/H/2026 Acs Dobfar S.p.A. Italy 2026-01-23 COMPLIANT
IT-API/87/H/2025 Acs Dobfar S.p.A. Italy 2025-05-07 COMPLIANT
IT/182/H/2026 Acs Dobfar S.p.A. Italy 2024-12-13 COMPLIANT
NBF/6/2025/V Acs Dobfar S.p.A. Italy 2024-10-17 COMPLIANT
IT/243/H/2024 Acs Dobfar S.p.A. Italy 2024-10-16 COMPLIANT
IT/123/H/2024 Acs Dobfar S.p.A. Italy 2024-05-10 COMPLIANT
NBF/39/2024/V Acs Dobfar S.p.A. Italy 2024-04-24 COMPLIANT
NBF/36/2024/V Acs Dobfar S.p.A. Italy 2024-03-27 COMPLIANT
IT-API/111/H/2024 Acs Dobfar S.p.A. Italy 2024-03-15 COMPLIANT
IT/44/H/2024 Acs Dobfar S.p.A. Italy 2023-12-15 COMPLIANT
IT-API/106/H/2024 Acs Dobfar S.p.A. Italy 2023-11-23 COMPLIANT
IT/89/H/2024 Acs Dobfar S.p.A. Italy 2023-11-23 COMPLIANT
IT-API/12/H/2024 Acs Dobfar S.p.A. Italy 2023-05-26 COMPLIANT
IT-API/72/H/2023 Acs Dobfar S.p.A. Italy 2022-10-14 COMPLIANT
IT-API/56/H/2023 ACS DOBFAR S.P.A. Italy 2022-09-23 COMPLIANT
IT-API/163/H/2021 Acs Dobfar S.p.A. Italy 2021-07-16 COMPLIANT
IT-API/30/H/2022 Acs Dobfar S.p.A. Italy 2021-07-16 COMPLIANT
NBF/15/2020/V ACS Dobfar S.p.A. Italy 2020-01-30 COMPLIANT
NBF/8/2021/V ACS Dobfar S.p.A. Italy 2020-01-30 COMPLIANT
IT-API/247/H/2020 ACS DOBFAR S.P.A Italy 2019-12-13 COMPLIANT
IT-API/42/H/2020 ACS DOBFAR S.P.A Italy 2019-12-13 COMPLIANT
IT-API/48/H/2021 ACS DOBFAR S.P.A. Italy 2019-07-19 COMPLIANT
NBF/26/2019/V ACS DOBFAR S.p.A. Italy 2019-03-26 COMPLIANT
IT-API/125/H/2020 ACS DOBFAR S.P.A. Italy 2019-03-01 COMPLIANT
IT-API/154/H/2021 ACS DOBFAR S.P.A. Italy 2019-03-01 COMPLIANT
IT-API/97/H/2020 ACS DOBFAR S.P.A. Italy 2019-03-01 COMPLIANT
IT-API/142/H/2019 ACS DOBFAR S.P.A. Italy 2018-12-14 COMPLIANT
IT-API/226/H/2022 Acs Dobfar S.p.A. Italy 2018-10-26 COMPLIANT
IT-API/88/H/2022 Acs Dobfar S.p.A. Italy 2018-10-26 COMPLIANT
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 ACS Dobfar

How many FDA inspections does ACS Dobfar have on record?
CDMO Signal tracks 7 FDA inspections for ACS Dobfar, sourced from the FDA inspection database. See the full inspection history above.
Has ACS Dobfar received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for ACS Dobfar.
Does ACS Dobfar hold EMA or MHRA GMP certificates?
CDMO Signal tracks 31 EMA GMP certificates for ACS Dobfar.
Does ACS Dobfar have a CDMO Signal Score?
Not yet. ACS Dobfar is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
Evaluating ACS Dobfar for a manufacturing program?
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