Suppliers / Haupt Pharma Latina

Haupt Pharma Latina

Italy Updated 9 July 2026

Haupt Pharma Latina is a finished-dose manufacturer based in Italy. It appears in 18 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), NAFDAC (NG) and INVIMA (CO). Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 29 July 2022 as VAI.

0
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
18
filings across 5 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 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

  • 29 July 2022 VAI US FDA
  • 28 June 2018 VAI US FDA
  • 16 December 2016 VAI US FDA
  • 4 November 2014 VAI US FDA
  • 12 December 2012 VAI US FDA
  • 13 October 2009 NAI US FDA

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

Registered plants

Site FDA FEI
Latina, United Arab Emirates Not on file
Latina, Italy Not on file
Italy, Italy 3007687501

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 6 None
NAFDAC (NG) 4 None
INVIMA (CO) 4 None
MINSA (CR) 2 None
FDA (GH) 2 None
EMA None 4

Questions about Haupt Pharma Latina

Does Haupt Pharma Latina hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Haupt Pharma Latina. It does have 18 filings with 5 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Haupt Pharma Latina FDA-registered?
One site operated by Haupt Pharma Latina carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Haupt Pharma Latina's last inspection go?
The most recent inspection on record closed on 29 July 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Haupt Pharma Latina manufacture?
3 registered sites are on record, in United Arab Emirates and Italy (Latina and Italy among others). Every site is listed on this page with the register it came from.
Which regulators recognise Haupt Pharma Latina's GMP?
Current GMP certificates are on record from EMA. 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 VAI, on 29 July 2022.

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Sources on this page

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