Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 90

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 90
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 others. The failure by us or our third-party manufacturers
to obtain the raw materials or APIs necessary to manufacture sufficient quantities of our product candidates, may have a material adverse
effect on our business.

Our third-party manufacturers
are subject to inspection and approval by regulatory authorities before we can commence the manufacture and sale of any of our product
candidates, and thereafter are subject to ongoing inspection from time to time. Our third-party manufacturers may not be able to comply
with cGMP regulations or similar regulatory requirements outside of the United States. Our failure, or the failure of our third-party
manufacturers, to comply with applicable regulations could result in regulatory actions, such as the issuance of notices of inspectional
observations, warning letters or sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays,
suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates or commercial products (if any),
operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our products. If any
of our third-party suppliers fails to comply with cGMP or other applicable manufacturing regulations, our ability to develop and commercialize
our product candidates could suffer significant interruptions.

| 44 |

Any disruption, such as a
fire, natural hazards or vandalism at our CMOs, or any impacts on our CMOs due to health pandemics, could significantly interrupt our
manufacturing capability. We currently do not have alternative production plans in place or disaster-recovery facilities available. In
case of a disruption, we will have to establish alternative manufacturing sources. This would require substantial capital on our part,
which we may not be able to obtain on commercially acceptable terms or at all. Additionally, we would likely experience months of manufacturing
delays as we build facilities or locate alternative suppliers and seek and obtain necessary regulatory approvals. If this occurs, we will
be unable to satisfy manufacturing needs on a timely basis, if at all. If changes to CMOs occur, then there also may be changes to manufacturing
processes inherent in the setup of new operations for our product candidates and any products that may obtain approval in the future.
Any such changes could require the conduct of bridging studies and regulatory approval before we can use any materials produced at new
facilities or under new processes in clinical trials or, for any products reaching approval, in our commercial supply. Further, business
interruption insurance may not adequately compensate us for any losses that may occur and