GlaxoSmithKline plc
Overview
GlaxoSmithKline plc is a global healthcare company that focuses on developing and manufacturing a wide range of pharmaceutical products, vaccines, and consumer healthcare goods. The company emphasizes innovation in the fields of pharmaceuticals and vaccines, aiming to improve global health and well-being.
Therapeutic areas
API / Drug Master Files
GlaxoSmithKline plc holds 10 active (25 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.
- FLUTICASONE PROPIONATEActive2018-08-22
- FLUTICASONE FUROATEActive2017-09-08
- FLUTICASONE PROPIONATEActive2017-04-11
- UMECLIDINIUM BROMIDEActive2012-11-29
- VILANTEROL TRIFENATATE (GW642444)Active2012-06-19
- ALBUTEROLActive2011-12-21
- SALMETEROL XINAFOATEActive2011-03-23
- CEFUROXIME SODIUMActive2011-03-01
- CEFTAZIDIMEActive2011-03-01
- PAROXETINE HYDROCHLORIDE HEMIHYDRATEActive2000-09-15
- CLOBETASOL PROPIONATEInactive2012-12-20
- AMOXICILLIN SODIUMInactive2011-02-11
- TICARCILLIN DISODIUM BULK (STERILE )Inactive2002-07-31
- CLAVULANATE POTASSIUM STERILE BULKInactive2002-06-13
- HIV VACCINE (GPL 120/NEFTA/ASO2A)Inactive2001-10-04
Showing 15 of 25 Drug Master Files.
FDA compliance signals
25 FDA enforcement records linked to this company.
- recall — Class III2024-06-12
Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*, whereas the correct expiration date, which is on the tablet bottle label, is 2025-APR.
- 4832024-04-19
Complaint Handling Procedure
- recall — Class III2024-01-03
Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
- recall — Class III2022-06-01
Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
- recall — Class II2017-05-31
Defective Delivery System: Elevated number of units with out of specification results for leak rate
- recall — Class II2017-04-12
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
- recall — Class II2016-07-27
Penicillin Cross Contamination
- recall — Class II2016-07-27
Penicillin Cross Contamination
- recall — Class II2016-07-27
Penicillin Cross Contamination
- recall — Class II2016-07-27
Penicillin Cross Contamination
- 4832016-04-21
Complaint Handling Procedure
- 4832016-04-21
Investigations of discrepancies, failures
- recall — Class II2015-12-16
Defective Delivery System: Some canisters may not contain sufficient propellant to deliver the labeled claim of 200 actuations through the end of shelf life.
- recall — Class II2015-09-02
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
- recall — Class II2015-09-02
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
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