ImprimisRx’s FDA-Registered Outsourcing Facility Issued California License
SAN DIEGO, Dec. 10, 2019 (GLOBE NEWSWIRE) -- ImprimisRx, the nation’s leading ophthalmic-focused outsourcing facility and pharmaceutical compounding business, a wholly-owned subsidiary of Harrow Health, Inc. (NASDAQ: HROW), announced that on December 9, 2019, its FDA-registered 503B outsourcing facility received a non-resident operating license and has now begun shipping into California. This license allows California-based ophthalmologists, optometrists, surgery centers and hospitals to efficiently order and stock ImprimisRx’s more than 40 ophthalmic products for on-demand administration to their patients.
John Saharek, President of ImprimisRx, commented, “Our team is excited to begin serving our home state of California, and its nearly 40 million residents, with high-quality ophthalmic formulations from our FDA-registered 503B outsourcing facility. We are grateful the State of California has issued this permit, one that has been granted to only a select few of the outsourcing facilities registered with the FDA.”
Mr. Saharek concluded, “The expected impact to ImprimisRx from this new license cannot be understated. While our business as a whole continues to grow nationally, we now expect California demand to significantly pick-up, and for California-specific sales to increase as a percentage of our overall revenue. This California 503B license is coming at a great time as recent investments we’ve made in automated equipment, personnel, and training are expected to increase our production capacity, easily allowing us to absorb the anticipated new demand.
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About ImprimisRx
ImprimisRx is the nation’s leading ophthalmology-focused outsourcing facility and pharmaceutical compounding business, serving thousands of ophthalmologists and optometrists in all 50 states, with 40 proprietary ophthalmic formulations. ImprimisRx is headquartered in San Diego, CA and owns two FDA-inspected production and dispensing facilities in Ledgewood, New Jersey. There have been over three million eyes served by the formulations produced at these facilities. For more information about ImprimisRx, including ordering instructions, please visit our website, .
About Harrow Health
Harrow Health, Inc. (NASDAQ: HROW) owns a portfolio of healthcare businesses, including , the nation’s leading ophthalmology outsourcing facility and pharmaceutical compounding business. The company holds large equity positions in , , , Mayfield Pharmaceuticals, Stowe Pharmaceuticals, and Radley Pharmaceuticals, all companies founded as subsidiaries of Harrow Health. The Company also owns royalty rights in certain drug candidates being developed by Surface, Melt, Mayfield and Radley. Harrow intends to create, invest in and grow paradigm shifting healthcare businesses that put patients first. For more information about Harrow Health, please visit the Investor Relations section of the corporate website by .
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to make commercially available our compounded formulations and technologies in a timely manner or at all; physician interest in prescribing our formulations; risks related to our compounding pharmacy operations; our ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of our formulations; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our expenses and cash burn, and raise additional funds when necessary; risks related to research and development activities; the projected size of the potential market for our technologies and formulations; unexpected new data, safety and technical issues; regulatory and market developments impacting compounding pharmacies, outsourcing facilities and the pharmaceutical industry; competition; and market conditions. These and additional risks and uncertainties are more fully described in Harrow Health’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC's web site at . Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow Health undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
No ImprimisRx compounded formulation is FDA-approved. Other than drugs compounded at a registered outsourcing facility, all ImprimisRx compounded formulations require a prescription for an individually identified patient consistent with federal and state laws.
Investor Contact:
Jon Patton
858-704-4587
Media Contact:
Deb Holliday
Holliday Communications, Inc.
412.877.4519
Source: ImprimisRx and Harrow Health, Inc.
