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Otsuka Holdings (4578) · RiskRestated

Risks Related to Pharmaceutical Regulations and Revocation of Licenses and Approvals

First written in FY2016. 2 of 3 entries say "Restated". Latest entry: FY2023.

3entries
8years
0from disclosures
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How it moved
ProgressHeldSoftenedWorseRestatedFY2016 – FY20232017: 120172018: 120182019: 020192020: 020202021: 020212022: 020222023: 020232024: 1
Same theme, other companies
Regulatory and licensing continuity risk in the pharmaceutical and long-term care businessesA theme 25 companies write about · 25 as a headwind · 0 as a tailwind

The whole theme swung hardest in 2021: 2 of 14 companies on the "Worse" side.

16 other companies' latest entry also says "Restated".

Ridges = years it wrote progress, valleys = years it wrote worse. Most hopeful companies at the back. Drag to turn, scroll to zoom, right-drag to pan. On a phone, two fingers turn and pinch to zoom; one finger scrolls the page.
Showing 14 of the 25 companies compared. The sentences above are computed from all 25.
Full recordFilings, disclosures and news, newest first
  1. FY2023RestatedAnnual report

    「If such licences and approvals are revoked due to violations of laws and regulations or other reasons, the Group may be required to recall products subject to regulation or discontinue their sale.」

    The company continues to disclose the risks of pharmaceutical regulations, revocation of licences and approvals, product recalls and sales discontinuation.
  2. FY2017RestatedAnnual report

    「As of the present time, no grounds for revocation of the relevant licences and approvals have arisen. However, if such licences and approvals are revoked due to violations of laws and regulations or other reasons, the Group may be required to recall products subject to regulation or discontinue their sale.」

    The company states that no grounds for revocation of licences and approvals have arisen as of the present time, while continuing to identify the risk of recalls and sales discontinuation due to violations of the Pharmaceuticals and Medical Devices Act and other laws and regulations.
  3. FY2016First statedAnnual report

    「If such licences and approvals are revoked due to violations of laws and regulations or other reasons, the Group may be required to recall products subject to regulation or discontinue their sale, and may be unable to continue the relevant business. This could disrupt the Group's operations and have a material impact on its business activities.」

    The company describes the risks of violations of the Pharmaceuticals and Medical Devices Act and other laws and regulations, revocation of licences and approvals, product recalls and sales discontinuation.
Moved together

None of this company's other threads moved the same way in the same document twice or more.

When this could move next
Otsuka Holdings's next results are scheduled for 2026-10-30. Read the earnings preview
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Risks Related to Pharmaceutical Regulations and Revocation of Licenses and Approvals | Otsuka Holdings Co.,Ltd. (4578) | Komori