On May 11, 2021 Upsher-Smith Laboratories reported that (Press release, Upsher-Smith Laboratories, MAY 11, 2021, View Source [SID1234580140])
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Overall Japan: In February 2020, Sawai Pharmaceutical assembled a Crisis Management team and implemented thorough measures to prevent infection.
US: In March 2020, USL assembled a cross-functional Crisis Response Team to gather and review information and to develop and implement applicable policies and processes. USL transitioned to a remote working model, with the exception of critical workers who needed to remain on-site, and also shifted to a digitally based sales and marketing. Japan: Under the state of emergency declared by the government, due to medical institutions restricting inperson visits by Medical Representatives, the provision of medical information has shifted to delivery by online meetings, etc.
Sales of respiratory organ agents and antibiotics declined due to the decrease in the number of visits patients made to medical institutions. US: Shifted to digitally based sales and marketing due to restriction of in-person physician sales activities. Restriction of sales activities adversely impacted sales, including Tosymra, which was acquired in 2019. Japan: No significant impact on development schedule.
US: Several R&D projects have seen delays due to the shutdowns in US and OUS. Supply Chain Maintained stable supply function by thoroughly implementing infection prevention and control in Japan and the U.S. There has been no disruption in the importation of raw materials or logistics.Sawai’s Response to the Serious GMP Violation in the Japanese Generics Industry
2 Sawai’s internal action related to this matter Sawai’s action toward quality
・Our Quality Assurance Dept. internally disseminates all the product recall information of other companies and also shares Sawai products’ relevant information on the products related to the recall. (As needed.)
・In addition to information sharing, reconfirmed at all the factories a supervision system of accepting, weighing and adding APIs; a training system for factory workers; and a prevention system of mix-ups of APIs. (Implemented in Dec. 2020.
・Provided briefings on these cases to employees at all the factories and instruct to engage in operations strictly following procedures. (Implemented in Jan. 2021.
） To minimize quality-related risks, the following measures are taken;
・Ensure the quality of APIs in compliance with Good Manufacturing Practices (GMP).
・Implement a quality control system through constant confirmation of GMP compliance at manufacturing facilities. ・Adopt manufacturing and quality control measures based on the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S-GMP). Slight increase in net sales and the same level as the previous year in core operating income, despite the severe business environment in both Japan and the US.
Operating income decreased due to impairment loss on intangible assets in the US.