Hikma Pharmaceuticals PLC
Overview
Hikma Pharmaceuticals PLC is a multinational pharmaceutical company based in the United Kingdom. It specializes in developing, manufacturing, and marketing a wide range of branded and non-branded generic medicines across various therapeutic areas. The company plays a vital role in providing affordable healthcare solutions to patients worldwide.
API / Drug Master Files
Hikma Pharmaceuticals PLC holds 20 active (21 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.
- SOLRIAETOL HYDROCHLORIDEActive2022-12-28
- UMECLIDINIUM BROMIDEActive2021-04-25
- HIK-078Active2019-10-31
- HIK-079Active2019-04-01
- SUNITINIB L-MALATEActive2017-02-20
- METHYLPREDNISOLONE ACETATE USP (STERILE)Active2016-07-27
- NILOTINIB MONOHYDROCHLORIDE ANHYDROUSActive2015-12-29
- DASATINIB MONOHYDRATEActive2015-12-29
- ERLOTINIB HYDROCHLORIDEActive2015-05-28
- MILRINONE, USPActive2011-11-24
- GRANISETRON HYDROCHLORIDE USPActive2011-09-11
- NICARDIPINE HYDROCHLORIDEActive2009-11-16
- ZOLEDRONIC ACID USPActive2009-08-09
- ONDANSETRON HYDROCHLORIDE, USPActive2008-11-13
- OXANDROLONE USPActive2007-03-06
Showing 15 of 21 Drug Master Files.
FDA compliance signals
39 FDA enforcement records linked to this company.
- recall — Class II2026-05-06
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
- recall — Class II2025-08-06
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
- recall — Class I2024-08-28
Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
- 4832024-06-12
Scientifically sound laboratory controls
- 4832024-06-12
Procedures not in writing, fully followed
- 4832024-06-12
Procedures for non-sterile drug products
- recall — Class II2024-03-27
The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
- 4832023-09-29
Written record of investigation incomplete
- 4832023-09-29
Validation lacking for sterile drug products
- recall — Class II2023-05-24
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
- recall — Class II2023-01-04
Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
- recall — Class II2022-08-17
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
- recall — Class II2022-08-17
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
- recall — Class II2022-08-17
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
- recall — Class II2022-08-17
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
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