TAMPA, Fla. – August 20, 2020 – Romark, a research-based pharmaceutical company focused on the discovery, development and delivery of innovative new medicines, primarily in the field of infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s manufacturing facility in Manati, Puerto Rico for the production of ALINIA® (nitazoxanide) tablets, 500 mg and ALINIA® (nitazoxanide) for Oral Suspension, 100 mg/5mL in the U.S. market.
The new state-of-the-art facility encompasses approximately 35,000 square feet and is equipped with suites and equipment to produce tablets, powders and other oral solid dosage forms.
“This is a major milestone for us, as it allows us to expand our capacity to develop and deliver medicines,” said Marc Ayers, President and Chief Executive Officer of Romark.
Romark has invested more than $80 million in establishing its Puerto Rico operations and now employs 100 people in the manufacturing facility and an analytical laboratory it acquired in 2018. With a planned expansion of the facility, the company’s Puerto Rico operations are expected to grow to a total of approximately 400 employees over the next three years.
The Puerto Rico facility is strategic to the company’s plans to manufacture and distribute its investigational new drug, NT-300 (nitazoxanide extended-release tablets), which is currently undergoing Phase 3 clinical trials for both the prevention and treatment of COVID-19 and other viral respiratory illnesses.
Romark is a vertically-integrated, research-based pharmaceutical company focused on the discovery, development and delivery of innovative new medicines, primarily in the field of infectious diseases. Romark has operations in the United States, Puerto Rico and Europe, and it conducts research and development and commercializes its products globally.
Romark is a leader in developing new drugs for treating a broad range of seasonal, emerging and drug-resistant viral respiratory illnesses. It is also developing a new product aimed at inducing functional cure of chronic hepatitis B. Products discovered, developed and commercialized by Romark have been used to positively impact the lives of more than 400 million people worldwide.
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