Shionogi & Co., Ltd.
Overview
Shionogi & Co., Ltd. is a leading Japanese pharmaceutical company specializing in research, development, manufacturing, and marketing of pharmaceuticals. It is renowned for its expertise in infectious diseases, particularly with medications for HIV and influenza.
Therapeutic areas
API / Drug Master Files
Shionogi & Co., Ltd. holds 1 active (1 total) FDA Type II Drug Master File — 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.
- OSPEMIFENEActive2021-07-29
FDA compliance signals
9 FDA enforcement records linked to this company.
- recall — Class III2018-01-24
Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules
- recall — Class III2017-07-26
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
- recall — Class III2017-07-26
Failed Dissolution Specifications: Low dissolution results were obtained during stability testing
- recall — Class III2015-08-12
Failed Dissolution Specifications
- 4832015-02-02
Following/documenting laboratory controls
- 4832015-02-02
SOPs not followed / documented
- 4832015-02-02
Annual visual exams of drug products
- recall — Class II2012-07-04
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
- warning_letter2008-11-14
FDA Warning Letter (drug product)
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