Stable Supply and Global-Standard Production and Quality Control Systems
First written in FY2016. 9 of 22 entries say "Restated". Latest entry: 2026-09-10.
0 other companies' latest entry also says "Worsened".
- 2026-09-10WorsenedOccurring Fact
「In addition to the deficiencies identified during the inspection of the drug-substance manufacturing facility not having been fully resolved, deficiencies were identified during a newly conducted cGMP inspection of the facility of the contract manufacturer for the drug product, and corrective action was judged necessary.」
Deficiencies in quality control at the manufacturing facility and the contract manufacturer's drug-product facility were cited as the reasons for the FDA's complete response letter. - FY2026Progress in establishing two production sites, but implementation took longer than expectedAnnual report
「Although establishing a two-site manufacturing structure took longer than expected, steady progress was made. • Capital investment in overseas subsidiary Dalton Chemical Laboratories Inc. (DCL) • Promotion of the transfer of manufacturing technology from Japan to DCL」
Although establishing a two-site structure comprising DCL and the Takahagi Plant took longer than expected, the company proceeded with capital investment in DCL and the transfer of manufacturing technology from Japan. Meanwhile, some equipment under construction in Canada could not readily be used for its original purpose, requiring a revision of the plan. - FY2026-H1SoftenedAnnual report
「Following a review of its manufacturing structure, the group determined that some manufacturing equipment under construction could not readily be used for its original purpose. It therefore reduced the carrying amount to the recoverable amount and recorded an impairment loss of ¥169 million as an extraordinary loss.」
Following a review of its manufacturing structure, the company determined that some manufacturing equipment under construction in Canada could not readily be used for its original purpose, resulting in a revision to its stable-supply and production plans. - FY2025AdvancedAnnual report
「For Alz, switching from competing products progressed, and units delivered to medical institutions increased from the previous fiscal year. In addition, equipment maintenance at our plant to prepare for increased production was completed, resulting in higher shipment volumes than in the previous fiscal year.」
Equipment maintenance to prepare the plant for increased production capacity was completed, and an increase in shipment volumes was reported. - FY2025-H1AdvancedAnnual report
「Shipments have been adjusted due to maintenance of manufacturing equipment in preparation for increased production capacity at our plant, resulting in a year-on-year decline in our sales. The shipment adjustments resulting from this equipment maintenance are expected to continue through the third quarter, but shipment volumes are expected to recover in the fourth quarter, bringing sales in line with the plan.」
With respect to production and quality management systems, the company is carrying out equipment maintenance to prepare the plant for increased production capacity. Shipment adjustments are expected to continue through the third quarter, but shipment volumes are expected to recover in the fourth quarter. - FY2023-Q3ReframedAnnual report
「We will further strengthen stable supply under an appropriate and efficient manufacturing system by establishing a two-site structure comprising our overseas subsidiary Dalton Chemical Laboratories Inc. in Toronto, Canada, and our Takahagi Plant in Ibaraki, Japan.」
The policy of stable supply and improved production efficiency has been concretized through the establishment of a global two-site production system comprising Dalton in Canada and the Takahagi Plant in Japan. - FY2021AdvancedAnnual report
「We will continue to optimize and improve production by progressively bringing in-house the manufacture of chemically synthesized products currently outsourced and transferring the manufacture of clinical trial materials and some of our products to Dalton.」
The transfer of manufacturing to the newly consolidated Dalton subsidiary has progressed to the stage of progressively bringing in-house the manufacture of chemically synthesized products and transferring the manufacture of clinical trial materials and some products. - FY2020AdvancedAnnual report
「In addition to using Dalton's technologies and know-how in new drug development, we will optimize and improve production by bringing in-house the manufacture of chemically synthesized products currently outsourced and transferring the manufacture of clinical trial materials and some of our products.」
Through the conversion of Dalton into a subsidiary, the company concretized the use of its technologies in new drug development, the in-house manufacture of chemically synthesized products, and production optimization through the transfer of clinical trial material and product manufacturing. - FY2020-Q3RestatedAnnual report
「For manufacturing costs, we will further review procurement costs and optimize and improve production efficiency through projects already under way, thereby securing product profitability.」
The company continues to pursue measures to secure product profitability through a review of procurement costs and production optimization and efficiency improvements. - FY2020-Q2RestatedAnnual report
「For manufacturing costs, we will further review procurement costs and optimize and improve production efficiency through projects already under way, thereby securing product profitability.」
The company continues to prioritize productivity-improvement measures to secure profitability through a review of procurement costs, production optimization and efficiency improvements, and reductions in selling, general and administrative expenses under its medium-term management plan. - FY2019AdvancedAnnual report
「To strengthen global-standard management systems, including for existing products, we renovated manufacturing equipment and introduced a new quality management system. In addition, we engaged specialist consultants to improve operations at the Takahagi and Kurihama plants, worked to improve production efficiency, and pursued cost-reduction measures through various initiatives, achieving a certain level of results.」
The company reported certain results from renovating manufacturing equipment, introducing a new quality management system, improving plant operations with specialist consultants, and reducing costs. - FY2019-Q3RestatedAnnual report
「• In addition to ensuring a stable supply of products, we will reduce costs by further improving production efficiency. • We will strengthen production and quality management systems based on global standards that can respond rapidly to regulatory developments.」
The company continues to prioritize stable supply, cost reduction through improved production efficiency, and the strengthening of global-standard production and quality management systems. - FY2019-Q2RestatedAnnual report
「• In addition to ensuring a stable supply of products, we will reduce costs by further improving production efficiency. • We will strengthen production and quality management systems based on global standards that can respond rapidly to regulatory developments.」
The company continues to prioritize stable supply, cost reduction through improved production efficiency, and the strengthening of global-standard production and quality management systems. - FY2018-Q3RestatedAnnual report
「In addition to ensuring a stable supply of products, we will reduce costs by further improving production efficiency. We will strengthen production and quality management systems based on global standards that can respond rapidly to regulatory developments.」
The company has reiterated stable supply, cost reduction through improved production efficiency, and the strengthening of global-standard production and quality management systems as key initiatives. - FY2018-Q1RestatedAnnual report
「To this end, we will strengthen the production and quality management systems required to meet global standards.」
The company continues to set stable supply, improved production efficiency, cost reduction, and the strengthening of global-standard production and quality management systems as priorities. - FY2017RestatedAnnual report
「To this end, we will strengthen the production and quality management systems required to meet global standards.」
The company continues to pursue stable supply, improved production efficiency, cost reduction, and the strengthening of global-standard production and quality management systems. - FY2017-Q3RestatedAnnual report
「To this end, we will strengthen the production and quality management systems required to meet global standards.」
The company has reiterated stable product supply, improved production efficiency, cost reduction, and the strengthening of global-standard production and quality management systems as key strategies. - FY2017-Q1RestatedAnnual report
「In addition to ensuring a stable supply of products, we will reduce costs by further improving production efficiency. We will strengthen production and quality management systems based on global standards that can respond rapidly to regulatory developments.」
The company has reiterated stable supply, improved production efficiency, cost reduction, and the strengthening of global-standard production and quality management systems as key strategies. - FY2016First statedAnnual report
「In addition to ensuring a stable supply of products, we will reduce costs by further improving production efficiency. We will strengthen production and quality management systems based on global standards that can respond rapidly to regulatory developments.」
Under the previous medium-term management plan, the company completed several large-scale capital investments, including the No. 5 Formulation Building at the Takahagi Plant, and concluded that it had established a system for stable supply over the medium to long term.