Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 98

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 98
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 manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping,
conduct of post-marketing studies and submission of safety, efficacy and other post-market information, including both federal
and state requirements in the United States and requirements of comparable foreign regulatory authorities, all of which will require
us to incur significant costs and expenses. In addition, we will be subject to continued compliance with the Current Good Manufacturing
Practices (“cGMP”) and Good Clinical Practices (“GCP”) requirements for any clinical trials that
we conduct post-approval.

If we do not comply with regulatory requirements and applicable standards
or if problems occur after a product reaches the market, the FDA or European Medicines Agency may impose consent decrees or withdraw approval.
Later discovery of previously unknown problems with our product candidates, including adverse events of unanticipated severity or frequency,
or with our third-party manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in,
among other things:

●restrictions on the marketing or manufacturing of our products,
withdrawal of the product from the market or voluntary or mandatory product recalls;

●manufacturing delays and supply disruptions where regulatory
inspections identify observations of noncompliance requiring remediation;

●revisions to the labeling, including limitation on approved
uses or the requirement of additional warnings, contraindications or other safety information, including boxed warnings;

●imposition of a Risk Evaluation and Mitigation Strategy (“REMS”),
which may include distribution or use restrictions;

●requirements to conduct additional post-market clinical
trials to assess the safety of the product;

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●fines, warning letters or holds on clinical trials;

●refusal by the FDA to approve pending applications or supplements
to approved applications filed by us or suspension or revocation of license approvals;

●product seizure or detention or refusal to permit the import
or export of our product candidates; and

●injunctions or the imposition of civil or criminal penalties.

The FDA’s, European Medicines Agency’s and other regulatory
authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory
approval of our product candidates. We cannot predict the likelihood, nature or extent of government regulation that may arise from future
legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing
requirements or the adoption of new requirements or policies, or if we are not able to maintain