Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 74

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 74
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 drug candidates, which would have a material adverse
effect on our business.

We are and will be completely dependent on
third parties to manufacture our branded drug products and drug candidates, and our commercialization of our drug candidates could be
halted, delayed or made less profitable if those third parties fail to obtain manufacturing approval from the FDA or comparable foreign
regulatory authorities, fail to provide us with sufficient quantities of our drug candidates or fail to do so at acceptable quality levels
or prices. 

We do not currently have, nor
do we plan to acquire, the capability or infrastructure to manufacture the active pharmaceutical ingredient (“API”) in our
drug candidates for use in our clinical trials or for commercial product. In addition, we do not have the capability to manufacture any
of our branded drug products and candidates as a finished drug product for commercial distribution. As a result, we are and will be obligated
to rely on contract manufacturers.

The facilities used by our contract
manufacturers to manufacture our drug products and candidates must be approved by the FDA or comparable foreign regulatory authorities
pursuant to inspections that will be conducted after we submit an NDA or BLA to the FDA or their equivalents to other relevant regulatory
authorities. We will not control the manufacturing process of, and will be completely dependent on, our contract manufacturing partners
for compliance with cGMPs for manufacture of both active drug substances and finished drug products. These cGMP regulations cover all
aspects of the manufacturing, testing, quality control and record keeping relating to our drug candidates. If our contract manufacturers
do not successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others,
they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities. If the FDA or a comparable foreign
regulatory authority does not approve these facilities for the manufacture of our drug candidates or if it withdraws any such approval
in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain
regulatory approval for or market our drug candidates, if approved.

 44 

Our contract manufacturers are
subject to ongoing periodic unannounced inspections by the FDA and corresponding state and foreign agencies for compliance with cGMPs
and similar regulatory requirements. We do not have control over our contract manufacturers’ compliance with these regulations
and standards. Failure by any of our contract manufacturers to comply with applicable regulations could result in sanctions being imposed
on us, including fines, injunctions