Company: HROW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001641172-25-000925
Chunk: 4

Company: HARROW, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 4
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 compound large quantities of drugs without a prescription
and distribute them out of state with certain limitations, such as the formulation appearing on the FDA’s drug shortage list or
the bulk drug substances contained in the formulations appearing on the FDA’s “clinical need” list. Entities voluntarily
registering with FDA as outsourcing facilities are subject to additional requirements that do not apply to compounding pharmacies (operating
under Section 503A of the FDCA), including adhering to standards such cGMPs or other FDA guidance documents and being subject to regular
FDA inspection. 

We operate
two compounding facilities located in Ledgewood, New Jersey. Our New Jersey operations are comprised of two separate entities and facilities,
one of which is registered with the FDA as an outsourcing facility (“NJOF”) under Section 503B of the FDCA. The other New
Jersey facility (“RxNJ”) is a licensed pharmacy operating under Section 503A of the FDCA. All of our compounded products
that we sell, produce and dispense are made in the U.S.

We believe
that, with our current compounding pharmacy facilities and licenses and FDA registration of NJOF, we have the infrastructure to scale
our business appropriately under the current regulatory landscape and meet the potential growth in demand we are targeting. We plan to
invest in one or both of our facilities to further their capacity and efficiencies. Also, we may seek to access greater pharmacy and
production related redundancy and markets through acquisitions, partnerships or other strategic transactions. 

Carved-Out Subsidiaries
(De-Consolidated Businesses)

We have
ownership interests in Melt Pharmaceuticals, Inc. (“Melt”) and Surface Ophthalmics, Inc. (“Surface”) and hold
royalty interests in some of Surface’s and Melt’s drug candidates. These companies are pursuing market approval for their
drug candidates under the FDCA, including in some instances under the abbreviated
pathway described in Section 505(b)(2), which permits the submission of a new drug application (an “NDA”) where at least
some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has
not obtained a right of reference. We previously held ownership interest in Eton Pharmaceuticals, Inc. (“Eton”) and sold
such interests in April 2024.

 6 

Melt Pharmaceuticals,
Inc.

Melt
is a clinical-stage pharmaceutical company focused on the development and commercialization of proprietary non-intr