For 25 years, Morunda has been interviewing leaders in Japan’s pharmaceutical and medical device industry. Most country managers typically come from a commercial background, rooted in sales and marketing. It’s rare to find country managers who come from finance or…
Kobayashi Kako Launches Another Recall for Itraconazole, Class II This Time
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
- 2nd Death Reported for Tainted Itraconazole User, Doctor Says Causal Link Unlikely
December 18, 2020
- Kobayashi Kako Manually Managed Itraconazole Production; Hand-Written Record on Rilmazafone Mix-Up Found
December 17, 2020
- Kobayashi Kako Temporary Halts Shipments of All Products after Tainted Itraconazole Issue
December 15, 2020
- 1st Death Reported for Kobayashi Kako’s Tainted Itraconazole Product
December 14, 2020
- Kobayashi Kako Recalls Trigger Shipment Control for Kaken's Itraconazole Product
December 11, 2020
- Pharmacist Group Chief Appalled at Itraconazole Recalls; 84 Cases of Health Damages Reported
December 10, 2020
- With Contaminated Itraconazole, Patients Might Have Taken Sleep Inducer at 10-20 Times Regular Dosage
December 9, 2020
- Kobayashi Kako Recalls Itraconazole over Hypnotic Contamination; Side Effects Confirmed
December 7, 2020
BUSINESS
- Japan Pharma Market Projected to Cross 12 Trillion Yen in FY2029: IQVIA
November 29, 2024
- Leqembi Now Available in South Korea: Eisai
November 29, 2024
- Pfizer Files Migraine Drug Rimegepant in Japan
November 28, 2024
- Dermatologist Hails Bimzelx as New Option for HS: UCB Seminar
November 27, 2024
- Shionogi Chided for Violating Promotion Guidelines with Actair
November 27, 2024
The Japanese health ministry on December 22 approved a batch of medicines for additional indications, including Otsuka Pharmaceutical’s atypical antipsychotic Rexulti (brexpiprazole) and Zenyaku Kogyo’s anti-CD20 antibody Rituxan (rituximab).Rexulti is now newly indicated for the treatment of depression and depressive…
Authorized generic (AG) strategies taken by innovative drug makers might help soften the impact of generic competition in their businesses but such tactics might also accelerate the application of “G1”/“G2” price cuts for their off-patent brand-name medicines, a Jiho tally…
Japan’s health ministry announced new NHI prices to be applied in April under the FY2022 drug price revision in the official gazette on March 4, with the earlier application of so-called “G1” price cuts to be implemented for the first…