Manufacturing Quality and the Risk of Supply Stoppages for Raw Materials and Products
First written in FY2016. 7 of 9 entries say "Restated". Latest entry: FY2026.
2 other companies' latest entry also says "Restated".
- FY2026RestatedAnnual report
「The Group is working to ensure quality assurance and stable supply, including by developing a quality assurance system that incorporates requests to the supply chain and establishing a procurement management department, under regulations based on applicable laws and regulations, and is working to reduce these risks.」
The Group continues to address the risks associated with manufacturing quality and dependence on specific suppliers through its quality assurance system and procurement management. - FY2026-H1Additional measures to strengthen the supply systemAnnual report
「① Establishment of a domestic biosimilar supply system leveraging our extensive biosimilar expertise and the manufacturing capabilities of And Pharma's subsidiaries ② Establishment of an efficient manufacturing and supply system through optimization of manufacturing and quality control systems ③ Establishment of a collaborative system to resolve supply concerns regarding generic drugs through cooperation between originator and generic drug companies」
The objectives of the investment in アンドファーマ include establishing a domestic biosimilar supply system, manufacturing and quality control systems, and a collaborative system to resolve supply concerns regarding generic drugs. - FY2025RestatedAnnual report
「The Group takes all possible measures to ensure product quality, including quality assurance and requests to the supply chain, under regulations based on applicable laws and regulations. However, if quality issues or other problems caused by manufacturing defects occur at the Group's factories, or if supply of products, raw materials or other items dependent on specific suppliers is delayed or suspended for any reason despite the establishment of a procurement management department and the implementation of procurement management, product recalls, shipment delays or suspensions, shortages, revocation of licenses and permits, business suspensions or other administrative sanctions, and lower sales could have a material impact on operating results and financial condition.」
The risks associated with quality issues and dependence on specific suppliers have been reconfirmed, along with quality assurance, procurement management and the target for stable supply during the 25-27 period. - FY2022RestatedAnnual report
「Although the Group has established a procurement management department and conducts procurement management for products, raw materials and other items dependent on specific suppliers, if supply is delayed or suspended for any reason, product recalls, shipment delays or suspensions, shortages, revocation of licenses and permits, business suspensions or other administrative sanctions, and lower sales could have a material impact on operating results and financial condition.」
The risks of product recalls, shipment suspensions, shortages and administrative sanctions arising from manufacturing quality issues and dependence on specific suppliers, as well as measures through procurement management, have been reconfirmed. - FY2021RestatedAnnual report
「If manufacturing defects or other quality issues occur at the Group's factories, or if the supply of products, raw materials or other items sourced from specific business partners is delayed or stopped for any reason despite the establishment of a procurement management department and the implementation of procurement management, this may result in recalls of commercial products, shipment delays or stoppages, stockouts, cancellation of licenses and approvals, business suspension or other administrative sanctions, and sales declines, and may have a material impact on operating results and financial condition.」
The risks of product recalls, shipment suspensions, shortages and administrative sanctions arising from manufacturing quality issues and dependence on specific suppliers have been reconfirmed, and measures through procurement management are also described. - FY2020RestatedAnnual report
「If manufacturing defects or other quality issues occur at the Group's factories, or if the supply of products, raw materials or other items sourced from specific business partners is delayed or stopped for any reason despite the establishment of a procurement management department and the implementation of procurement management, this may result in recalls of commercial products, shipment delays or stoppages, or stockouts, and may have a material impact on operating results and financial condition.」
The risk of supply stoppages due to manufacturing quality issues and dependence on specific business partners for supply is reaffirmed, along with the response through procurement management. - FY2019RestatedAnnual report
「If manufacturing defects or other quality issues occur at the Group's factories and lead to product recalls, or if the supply of products, raw materials or other items sourced from specific business partners is delayed or stopped for any reason, this may have a material impact on operating results and financial condition.」
The risk of supply stoppages due to manufacturing quality issues and dependence on specific business partners for supply is reiterated. - FY2018RestatedAnnual report
「If manufacturing defects or other quality issues occur at the Group's factories and lead to product recalls, or if the supply of products, raw materials or other items sourced from specific business partners is delayed or stopped for any reason, this may have a material impact on operating results and financial condition.」
The risk of supply stoppages due to manufacturing quality issues and dependence on specific business partners for supply is reiterated. - FY2016First statedAnnual report
「If the supply of products, raw materials or other items sourced from specific business partners is delayed or stopped for any reason, this may have a material impact on operating results and financial condition.」
Manufacturing quality issues at factories and dependence on specific business partners for supply are presented together.