Company: OSRH
Filing Date: 2025-04-22
Form Type: 10-K
Source: 0001213900-25-034116
Chunk: 129

Company: OSR Holdings, Inc.
Filing Date: 2025-04-22
Form: 10-K
Item: Item 1
Chunk 129
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 Additionally, if we advance
a biological candidate into IND-enabling studies, the manufacturing processes for biological products is more complex and expensive
than with small molecule products and additional manufacturing suppliers may be needed to manufacture clinical supplies for these programs.
If our manufacturers are unable to produce sufficient quantities for clinical trials or for commercialization, our development and commercialization
efforts would be impaired, which would have an adverse effect on our business, financial condition, results of operations and growth prospects.

The manufacture of drug products, and particularly biologics,
is complex and our third-party manufacturers may encounter difficulties in production. If any of our third-party manufacturers
encounter such difficulties, our ability to provide supply of our current product candidates or any future product candidates for clinical
trials or our products for patients, if approved, could be delayed or prevented.

Manufacturing drugs, particularly biologics, especially in large
quantities, is often complex and may require the use of innovative technologies to handle living cells. Each lot of an approved
biologic must undergo thorough testing for identity, strength, quality, purity and potency. Manufacturing biologics requires
facilities specifically designed for and validated for this purpose, and sophisticated quality assurance and quality control
procedures are necessary. Slight deviations anywhere in the manufacturing process, including filling, labeling, packaging, storage
and shipping and quality control and testing, may result in lot failures, product recalls or spoilage. When changes are made to the
manufacturing process, we may be required to provide preclinical and clinical data showing the comparable identity, strength,
quality, purity or potency of the products before and after such changes. If microbial, viral or other contaminations are discovered
at the facilities of our manufacturers, such facilities may need to be closed for an extended period of time to investigate and
remedy the contamination, which could delay clinical trials and adversely harm our business.

In addition, there are risks associated with large scale manufacturing
for clinical trials or commercial scale including, among others, cost overruns, potential problems with process scale-up, process reproducibility,
stability issues, compliance with good manufacturing practices, lot consistency and timely availability of raw materials. Even if we obtain
marketing approval for any of our current product candidates or any future product candidates, there is no assurance that our manufacturers
will be able to manufacture the approved product to specifications acceptable to the FDA or other comparable foreign regulatory authorities,
to produce it in sufficient quantities to meet the requirements for