Kobayashi Kako Slapped with Record 116-Day Business Suspension

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• MHLW Revokes Approval for 12 Kobayashi Kako Products, Imposes Biz Improvement Order
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• Kobayashi Kako Chief to Resign over Drug Mix-Up, Lousy Manufacturing and Cover-Ups
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• Kobayashi Kako Expelled from JGA over Drug Mix-Up
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• Regulators to Issue Biz Suspension Order to Kobayashi Kako on Feb. 9
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• Kobayashi Kako Notified of Record Biz Suspension of 110-Plus Days over Drug Mix-Up
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• Kobayashi Kako Submits Report on Drug Mix-Up, Could Face Administrative Penalty in 1st Half of February
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• Kobayashi Kako Expected to Face Administrative Penalty This Fiscal Year, Biz Suspension Likely
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• First Time FPMAJ’s Supply Coordination Scheme Invoked for 13 APIs Tied to Kobayashi Kako
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• Kobayashi Kako Adds 2 APIs to Class II Recall List, Meiji/Elmed Products
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• Kobayashi Kako Recalls 12 More APIs after On-Site Inspections
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• Results of On-Site Probe into Kobayashi Kako Due Out Early Next Year, MHLW Eyes Biz Suspension
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• 2nd Death Reported for Tainted Itraconazole User, Doctor Says Causal Link Unlikely
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• Kobayashi Kako Manually Managed Itraconazole Production; Hand-Written Record on Rilmazafone Mix-Up Found
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• Kobayashi Kako Recalls Trigger Shipment Control for Kaken's Itraconazole Product
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