Results of On-Site Probe into Kobayashi Kako Due Out Early Next Year, MHLW Eyes Biz Suspension
To read the full story
Related Article
- Kobayashi Kako Submits Biz Improvement Plan Over Fudged Drug Filings
May 31, 2021
- Biz Improvement Order Issued to 3 Codevelopers over Kobayashi Kako’s Fudged Data
May 24, 2021
- MHLW Revokes Approval for 12 Kobayashi Kako Products, Imposes Biz Improvement Order
April 30, 2021
- Kobayashi Kako Starts Recalling Products Subject to Approval Revocation
April 22, 2021
- Kobayashi Kako Chief Sorry for Fake Application Documents; Third-Party Report Reveals New Problems
April 19, 2021
- MHLW to Revoke Approval of 12 Kobayashi Kako Products as Documents Fabricated
April 19, 2021
- Kobayashi Kako’s Seima Factory Operations Still Halted Even after 60-Day Order Lifted
April 12, 2021
- Kobayashi Kako to Invite Outsider to Take Over Top Post: Biz Improvement Plan
March 11, 2021
- Meiji to Discontinue Sale of Kobayashi Kako Products after Biz Suspension
February 26, 2021
- 4 APIs/9 Products Excluded from Kobayashi Kako Biz Suspension for Medical Needs
February 24, 2021
- Kobayashi Kako Chief to Resign over Drug Mix-Up, Lousy Manufacturing and Cover-Ups
February 10, 2021
- Kobayashi Kako Expelled from JGA over Drug Mix-Up
February 10, 2021
- Kobayashi Kako Slapped with Record 116-Day Business Suspension
February 9, 2021
- Regulators to Issue Biz Suspension Order to Kobayashi Kako on Feb. 9
February 8, 2021
- Kobayashi Kako Might Face 116-Day Biz Suspension over Drug Mix-Up
January 27, 2021
- Kobayashi Kako Notified of Record Biz Suspension of 110-Plus Days over Drug Mix-Up
January 26, 2021
- Kobayashi Kako Submits Report on Drug Mix-Up, Could Face Administrative Penalty in 1st Half of February
January 21, 2021
- Kobayashi Kako Expected to Face Administrative Penalty This Fiscal Year, Biz Suspension Likely
January 12, 2021
- First Time FPMAJ’s Supply Coordination Scheme Invoked for 13 APIs Tied to Kobayashi Kako
January 5, 2021
- Kobayashi Kako Adds 2 APIs to Class II Recall List, Meiji/Elmed Products
December 28, 2020
- Kobayashi Kako Recalls 12 More APIs after On-Site Inspections
December 25, 2020
- MHLW Official Says Biz Suspension on Kobayashi Kako Inevitable
December 22, 2020
REGULATORY
- War-Linked Supply Concerns Rise to 43 Cases, Focus Shifts to Solvents, Packaging
April 24, 2026
- JPMA Pushes for “Freeze” on On-Patent Drug Price Cuts at LDP Meeting
April 23, 2026
- MHLW to Exclude High School-Age and Younger from OTC-Like Drug Charge: Official
April 23, 2026
- Japan, Singapore to Share GMP Inspection Results under Cooperation Pact
April 23, 2026
- MHLW Orders Label Revisions for Remicade, Enbrel, Bavencio, and More Drugs
April 22, 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…





