As COVID-19 puts a strain on global pharmaceutical supply lines, the U.S. government has scrambled to promote domestic manufacturing. Now, a Florida-based drugmaker with established ties to Puerto Rico has won a thumbs up to turn out its leading drug product—and supplies of an experimental treatment for COVID-19—at its manufacturing plant on the island territory.
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.
Romark announced today it will initiate two clinical trials of its investigational new drug candidate NT-300 (nitazoxanide extended-release tablets) for prevention of COVID-19 and other viral respiratory illnesses in high-risk populations, including elderly residents of long-term care facilities and healthcare workers.
TAMPA, Fla., April 27, 2020 /PRNewswire/ -- Romark announced today it will initiate two clinical trials of its investigational new drug candidate NT-300 (nitazoxanide extended-release tablets) for prevention of COVID-19 and other viral respiratory illnesses in high-risk populations, including elderly residents of long-term care facilities and healthcare workers.
Romark Lab initiates Class II recall of Alinia (nitazoxanide) manufactured for Lupin Pharmaceuticals