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 that the U.S. Food and Drug Administration has given its approval to the production of ALINIA, at its Manatí plant.
The $80 million, state-of-the-art facility opened a little more than a year ago, comprising some 35,000 square feet and is equipped with suites and equipment to produce tablets, powders and other oral solid dosage forms, company officials said.
“This is a major milestone for us, as it allows us to expand our capacity to develop and deliver medicines,” said Romark President Marc Ayers.
Romark 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,” officials said.
Romark has operations in the continental United States, Puerto Rico and Europe, and it conducts research and development and commercializes its products globally.