Quality and Supply Continuity Risks Associated with Third-Party Contract Manufacturers
First written in FY2021. 5 of 10 entries say "Materialised", first in FY2026-H1. Latest entry: 2026-08-07.
The whole theme swung hardest in 2024: 10 of 32 companies on the "Worse" side.
15 other companies' latest entry also says "Mitigated".
- FY2026MaterialisedAnnual report
「As stated in the notice concerning the suspension of transactions with a major business partner published on 9 September 2025, we suspended transactions with the contract manufacturer for Steboronin®, our product under development, because it entered bankruptcy proceedings on 5 September 2025.」
The previously identified risk to supply continuity, namely the business failure of the contract manufacturer, actually occurred. Production is being transferred to a new contract manufacturer and approval procedures are under way, but the possibility of an impact depending on the progress of the transfer remains. - FY2026-H1MaterialisedAnnual report
「As stated in the notice concerning the suspension of transactions with a major business partner published on 9 September 2025, we suspended transactions with the contract manufacturer for Steboronin®, our product under development, because it entered bankruptcy proceedings on 5 September 2025.」
The previously disclosed risk of a contract manufacturer's business failure actually occurred, requiring transactions to be suspended and production to be transferred. - FY2022RestatedAnnual report
「If a contract manufacturer becomes insolvent or has its business license revoked due to violations of laws and regulations, we may be forced to change contract manufacturers. As selecting an alternative company and completing manufacturing, validation and an application for partial approval changes for the pharmaceutical require a certain period, this may have a material effect on our financial position and operating results.」
The company continues to identify the risk of production delays due to quality issues, supply continuity concerns and business failures at external contract manufacturers, among other factors. - FY2021First statedAnnual report
「If a contract manufacturer suffers a disaster or other unforeseen event, such as damage to its manufacturing facilities, or if production lines are shut down or business suspension orders are imposed due to deficiencies in the manufacturer's production or quality control systems or violations of laws and regulations, product quality or stable supply may be disrupted.」
The company identifies supply disruptions caused by disasters affecting contractors, deficiencies in quality control, business suspensions and business failures, among other factors.