BUSINESS
Kyowa Hakko Bio’s GMP Breach Triggers Shipment Curbs, Stockouts at Astellas, Kowa; Impact Could Reverberate Further
GMP violations found at API supplier Kyowa Hakko Bio are spilling over into companies using its ingredients to manufacture final drug products, with Astellas Pharma and Kowa forced to curb their shipments for adenosine triphosphate (ATP) medicines and stock-outs expected…
To read the full story
Related Article
- All FAD Agents in Japan to Be Discontinued as Kyowa Hakko Bio Quits API Production
June 9, 2022
- Kyowa Hakko Bio Staffers Hid GMP Violations, Fearing Supply Halt: Report
February 4, 2020
- Kyowa Hakko Bio Hit with 18-Day Biz Suspension over GMP Failings
December 25, 2019
- Kyowa Kirin Recalling Mitomycin over Unauthorized Manufacturing Method, Supply Won’t Resume until 2021
October 18, 2019
BUSINESS
- AGC Biologics Launches Bispecific Antibody CDMO Project in Japan
May 28, 2026
- Bayer Regulatory Chief Hails Japan’s Review System, Flexibility on PI Waivers
May 28, 2026
- Asahi Kasei Licenses ADC Technology from Noguchi Institute
May 28, 2026
- Kissei Files Rigel’s AML Drug Olutasidenib in Japan
May 28, 2026
- Japan OTC Market Falls 2.4% in April amid Weaker Inbound Demand: Intage
May 28, 2026
In the complex landscape of the Japanese pharmaceutical market, the “status quo” is often the safest harbor. But for leaders like Kennet Brysting, former president of Gilead Japan, the status quo is the most dangerous place to stay.Innovation in Japan…





