Sawai Group Holdings Co (4887) investor relations material

Product development and growth strategy

• 2026 June launches included 9 products; multiple additional products were scheduled for December 2026.

• Product development focuses on patient and medical-workflow needs, including easier-to-take formulations, clearer labeling, safer packaging, and improved stability.

• Proprietary formulation technologies cover particle production, coating, rapid-disintegrating tablets, printing, and AI-based taste and aroma evaluation.

• Estimated market share was 16%; the strategy aims to expand share through product development, portfolio optimization, reliable technology transfers, and manufacturing strength.

Production capacity and stable supply

• Total theoretical group production capacity was 20.5 billion tablets as of September 2026, supported by multiple plants across Japan.

• Capacity expansion plans included Second Kyushu Plant Step 2 and the second and third Seima plants; production volume includes outsourced manufacturing.

• Productivity initiatives target larger manufacturing lots, simpler production methods, shorter lead times, fewer quality-related rejected batches, and higher yields.

• Portfolio reviews and discontinuation of uncompetitive or unprofitable small-lot products are intended to free capacity for core products; collaboration with Nichi-Iko supports production consolidation.

Quality assurance and operating model

• Quality plans combine plant-level autonomy with company-wide governance, MES/LIMS digitization, standardized plant practices, independent GMP audits, and faster escalation.

• A two-step ICH Q10 management-review process links shop-floor and divisional assessments to company-wide executive decisions on resources and corrective actions.

• New-product transfers follow preparation, implementation and verification, then commercialization and follow-up, with management reviews providing oversight and feedback.

• Quality-culture efforts use an ideal-state definition, regular surveys to quantify gaps, and targeted improvement actions, centered on patient safety and continuous quality improvement.