Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 89

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 89
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 acceptable quality levels or prices or fails to achieve or maintain satisfactory regulatory compliance.

We do not currently have,
and we do not plan to build, the infrastructure or capability internally to manufacture current product candidates or any future product
candidates for use in the conduct of our clinical trials or, if approved, for commercial supply. We rely on, and expect to continue to
rely on, contract manufacturing organizations, or CMOs. Reliance on third-party contractors may expose us to more risk than if we were
to manufacture our product candidates ourselves. Although our agreements with CMOs require them to perform according to certain cGMP requirements
such as those relating to quality control, quality assurance, maintenance of production and testing records, and qualified personnel,
we do not control the manufacturing processes of our CMOs, and we are dependent on such CMOs for the production of our product candidates
in accordance with cGMP and other relevant applicable regulations.

In complying with the manufacturing
regulations of the FDA and other comparable foreign regulatory authorities, we and our third-party manufacturers must spend significant
time, money and effort in the areas of design and development, testing, production, record-keeping and quality control to assure that
the product candidates meet applicable specifications and other regulatory requirements. If either we or our CMOs fail to comply with
these requirements, we may be subject to regulatory enforcement action, including the seizure of product candidates and shutting down
of production.

Even if we are able to establish
and maintain agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

| • | reliance on the third party for regulatory, compliance and quality assurance; |

| • | the possible breach of the manufacturing agreement by the third party; |

| • | the possible misappropriation of our proprietary information, including our trade secrets and know-how; 
 and                                                                                                     |

| • | the possible termination or nonrenewal of the agreement by the third party at a time that is costly or 
 inconvenient for us.                                                                                   |

We or our third-party manufacturers
may encounter shortages in the raw materials or APIs necessary to produce our product candidates in the quantities needed for our clinical
trials or, if our product candidates are approved, in sufficient quantities for commercialization or to meet an increase in demand, as
a result of capacity constraints or delays or disruptions in the market for the raw materials or active pharmaceutical ingredients, including
shortages caused by the purchase of such raw materials or APIs by our competitors or