Overview
Hospira is a subsidiary of Pfizer Inc., specializing in injectable drugs and infusion technologies. The company is known for its development and manufacturing of high-quality biosimilars and generic injectables.
Therapeutic areas
Active pharmaceutical ingredients supplied
Substances Hospira is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
Hospira holds 2 active (15 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- ISOPROTERENOL HYDROCHLORIDE DRUG SUBSTANCEActive2011-08-16
- VANCOMYCIN HYDROCHLORIDEActive1998-09-01
- NT100H DRUG SUBSTANCEInactive2012-09-28
- OXALIPLATIN DRUG SUBSTANCEInactive2010-11-15
- PAMIDRONIC ACID DRUG SUBSTANCEInactive2006-07-03
- ATHERO GENICS AGIX-4207 INJECTABLE EMULSIONInactive2001-08-15
- OFNE ADMIXTURE DRUG PRODUCTSInactive2000-04-28
- ROGOSIN EMULSIONInactive1999-06-28
- TEQUIN I.V. (GATIFLOXACIN)Inactive1998-12-21
- LAMISIL EMULSIONInactive1998-01-29
- CLEVIDIPINE EMULSIONInactive1995-02-23
- SPC-100270 EMULSIONInactive1992-12-16
- PFC EMULSIONInactive1992-11-17
- TIN ETHYL ETIOPURPURIN (TEP) EMULSION PROCESSING IN KUNGSANGEN AND STOCKHOLM, SWEDENInactive1992-06-29
- INTRAVENOUS FAT EMULSION PRODUCT 4501Inactive1987-10-05
FDA compliance signals
50 FDA enforcement records linked to this company.
- 4832025-01-17
Investigations of discrepancies, failures
- 4832025-01-17
Control procedures to monitor and validate performance
- 4832025-01-17
Procedures for sterile drug products
- 4832020-01-17
Written record of investigation incomplete
- 4832020-01-17
Control procedures to monitor and validate performance
- 4832020-01-17
Complete instructions, procedures, specifications et. al.
- 4832020-01-17
Procedures not in writing, fully followed
- 4832020-01-17
Exhaust systems inadequate to control air contamination
- 4832020-01-17
In-process conformity - examination, sample testing
- 4832020-01-17
Investigations of discrepancies, failures
- 4832020-01-17
Acceptance criteria for sampling & testing
- 4832020-01-17
Validation lacking for sterile drug products
- 4832020-01-17
SOPs not followed / documented
- 4832019-11-21
Scientifically sound laboratory controls
- 4832019-11-21
Investigations of discrepancies, failures
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