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
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
Procedures for sterile drug products
- 4832025-01-17
Investigations of discrepancies, failures
- 4832025-01-17
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
SOPs not followed / documented
- 4832020-01-17
Exhaust systems inadequate to control air contamination
- 4832020-01-17
Acceptance criteria for sampling & testing
- 4832020-01-17
Written record of investigation incomplete
- 4832020-01-17
Validation lacking for sterile drug products
- 4832020-01-17
Control procedures to monitor and validate performance
- 4832020-01-17
Investigations of discrepancies, failures
- 4832020-01-17
In-process conformity - examination, sample testing
- 4832019-11-21
Investigations of discrepancies, failures
- 4832019-11-21
Written record of investigation incomplete
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