Romark snares FDA nod to make diarrhea med Alinia at Puerto Rico plant—and supply a COVID-19 candidate's trials, too

Romark will leverage its plant in Manati, Puerto Rico, to help manufacture and distribute its COVID-19 fighter, NT-300, currently in phase 3 testing. (Romark)(Romark Laboratories)

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. 

Romark's manufacturing facility in Manati, Puerto Rico, snagged clearance from the FDA to produce the diarrhea med Alinia for the U.S. market, the company said in a release. The green light covers production of 500-milligram tablets and 100-milligram/5-milliliter oral suspension formulations of Alinia, known by the generic name nitazoxanide. 

The 35,000-square-foot facility boasts suites and equipment to produce tablets, powders and other oral solid dosage forms, Romark said. Plus, the company hopes to leverage the site for manufacturing and distribution of its investigational new drug, NT-300—an extended release tablet containing nitazoxanide—currently in testing against COVID-19. 

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In August, the Tampa, Florida-based pharma advanced NT-300 into a phase 3 trial in up to 800 subjects ages 12 and older with fever and respiratory symptoms consistent with COVID-19. That phase 3 follows two other active late-stage studies in high-risk populations, including elderly residents of long-term care facilities and healthcare workers. Romark plans to share results from its trials later this year, the company said in an email. 

Meanwhile, Romark has invested $80 million to expand operations in Puerto Rico, where the company employs 100 staffers at its manufacturing plant and an analytical laboratory acquired in 2018. Over the next three years, Romark aims to recruit around 300 new employees as it builds out its Puerto Rican sites, with plans to grow the Manati plant to more than 100,000-square-feet, the drugmaker said. 

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That cash infusion follows roughly half a decade of expansions and investments on the island. Romark first announced its plans to build the Manati plant in late 2014. At the time, the company pledged to invest $110 million in the site to shore up manufacturing work on Alinia, as well as NT-300, then in testing as a treatment for influenza. In August 2018, the company snagged Scienza Labs in Dorado, Puerto Rico, to boost manufacturing and research and development work at the Manati site. 

Earlier this year, the U.S. government called for increased drug manufacturing in Puerto Rico as one way to boost domestic drug supplies. In an interview with the Washington Examiner, White House trade adviser Peter Navarro cited a "broken system" that pushes manufacturing offshore and called on Congress to use its next round of COVID-19 relief to support Puerto Rican manufacturing.