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FDA Approves New Romark Manufacturing Facility in Puerto Rico

By on August 26, 2020

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Pharmaceutical says facility is strategic to plans to manufacture drug candidate in Phase 3 trials for prevention, treatment of COVID-19

SAN JUAN — Pharmaceutical company Romark, which develops medicines primarily in the field of infectious diseases, recently announced that the U.S. Food and Drug Administration (FDA) has approved its new manufacturing facility in the northern coastal town of Manatí, Puerto Rico, for the production of Alinia (nitazoxanide).

The company said the Puerto Rico facility is strategic to its 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. 

Alinia is currently used to treat diarrhea caused by Giardia lamblia or Cryptosporidium parvum. According to the Centers of Disease Control and Prevention (CDC), Giardia is “is a microscopic parasite that causes the diarrheal illness known as giardiasis.” It is found on surfaces including soil, food and water that has been contaminated with “feces from infected humans or animals.” 

Cryptosporidium, meanwhile, is a microscopic parasite “that causes the diarrheal disease cryptosporidiosis.” The disease and the parasite are commonly known as “Crypto.”  

The facility of about 35,000 square feet 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 CEO of Romark. 

Romark said it has invested more than $80 million in establishing its Puerto Rico operations and 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 about 400 employees over the next three years. 

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