FDA Approves Romark Facility in Puerto Rico

The U.S. Food and Drug Administration (FDA) has approved Romark’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 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 candidate, 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.