Suppliers / Hovione Scientia

Hovione Scientia

Ireland Updated 9 July 2026

Hovione Scientia is an API manufacturer based in Ireland. It appears in 3 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by EMA, US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 11 June 2025 as NAI.

0
active US DMFs
0
valid CEPs
3
registered plants 2 with an FDA FEI number
3
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 11 June 2025 NAI US FDA
  • 20 January 2023 NAI US FDA
  • 22 February 2022 VAI US FDA
  • 22 January 2020 VAI US FDA
  • 22 December 2017 NAI US FDA
  • 16 December 2015 VAI US FDA
  • 25 July 2014 NAI US FDA
  • 26 April 2013 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Ireland, Ireland 3008058822
East Windsor, United States 3006106736
EAST WINDSOR, United States Not on file

What they file, and where

Molecule Regulators Docs
Doxycycline SFDA (Saudi Arabia) 1
Minocycline SFDA (Saudi Arabia) 1
Regadenoson SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Doxycycline API Minocycline API Regadenoson API

Filings and GMP by regulator

Regulator Filings GMP certificates
INFARMED (PT) 3 None
EMA None 2
US FDA None 1
ANVISA (Brazil) None 1

Questions about Hovione Scientia

Does Hovione Scientia hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Hovione Scientia. It does have 3 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Hovione Scientia FDA-registered?
2 sites operated by Hovione Scientia carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Hovione Scientia's last inspection go?
The most recent inspection on record closed on 11 June 2025 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Hovione Scientia manufacture?
3 registered sites are on record, in Ireland and United States (Ireland, East Windsor and East Windsor). Every site is listed on this page with the register it came from.
What does Hovione Scientia make?
3 molecules are on record against Hovione Scientia, including Doxycycline, Minocycline and Regadenoson. Each links through to that molecule's full manufacturer list.
Which regulators recognise Hovione Scientia's GMP?
Current GMP certificates are on record from EMA, US FDA and ANVISA (Brazil). GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was NAI, on 11 June 2025.

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates