Suppliers / Hospira

Hospira

United States Updated 9 July 2026

Hospira is an API and finished-dose manufacturer based in United States. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its filings concentrate with US FDA, AIFA (IT) and FAMHP (BE). Its GMP standing is certified by MFDS (Korea), EAEU_EEC and ANVISA (Brazil), among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 7 February 2025 as NAI.

2
active US DMFs
0
valid CEPs
12
registered plants
5,863
filings across 41 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
0 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 7 February 2025 NAI US FDA
  • 17 January 2025 VAI US FDA
  • 27 March 2024 NAI US FDA
  • 17 January 2020 VAI US FDA
  • 21 November 2019 VAI US FDA
  • 15 August 2018 OAI US FDA
  • 2 February 2018 VAI US FDA
  • 27 October 2017 VAI US FDA

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

Registered plants

Site FDA FEI
Rocky Mount, United Arab Emirates Not on file
McPherson, United Arab Emirates Not on file
Ascoli Piceno (AP), United Arab Emirates Not on file
Kalamazoo, United Arab Emirates Not on file
Ascoli Piceno (AP), United Arab Emirates Not on file
Kalamazoo, United Arab Emirates Not on file

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Isoprenaline US FDA 1
Vancomycin US FDA 1

Also appears on these molecule pages

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Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 716 2
AIFA (IT) 653 None
FAMHP (BE) 611 None
EMA 436 None
INHRR (VE) 333 None
URPL (PL) 312 None
MFDS (Korea) None 6
EAEU_EEC None 6
ANVISA (Brazil) None 6
HSA (SG) None 4
MHRA (UK) None 2
NAFDAC (NG) None 2

Questions about Hospira

Does Hospira hold a US DMF or a CEP?
Hospira holds 2 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
How did Hospira's last inspection go?
The most recent inspection on record closed on 7 February 2025 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file, of which 1 closed as OAI.
Where does Hospira manufacture?
12 registered sites are on record, in United Arab Emirates, Belgium, Switzerland and Colombia (Rocky Mount, Mcpherson and Ascoli Piceno (ap) among others). Every site is listed on this page with the register it came from.
What does Hospira make?
2 molecules are on record against Hospira, including Isoprenaline and Vancomycin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Hospira's GMP?
Current GMP certificates are on record from MFDS (Korea), EEC (Eurasian Economic Union), ANVISA (Brazil), HSA (SG), US FDA and 2 more. 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

  • 81 active litigation matters are on record.
  • The most recent inspection outcome was NAI, on 7 February 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