Romark has constructed a state-of-the-art manufacturing facility in Manati, Puerto Rico. Credit: Romark.
The manufacturing facility received approval from the US Food and Drug Administration (FDA) in August 2020. Credit: Romark.
Romark’s Puerto Rico facility is dedicated for the production of Alinia® (nitazoxanide) tablets and oral suspension. Credit: Romark.

Romark has built a new manufacturing facility in Manati, Puerto Rico, for the production of its diarrhoea drug, Alinia® (nitazoxanide), for the US market.

The facility can also support the manufacturing and distribution of NT-300 (nitazoxanide extended-release tablets), an investigational drug for the prevention and treatment of COVID-19 and other viral respiratory infections, if approved. The drug is currently undergoing phase three clinical trials.

The Puerto Rico Industrial Development Company (PRIDCO) announced the development of Romark’s new manufacturing facility in Puerto Rico with an estimated investment of $110m in December 2014.

An old facility was repurposed with an investment of $80m to develop the new facility. The plant was inaugurated in May 2019, while the US Food and Drug Administration (FDA) approval was granted in August 2020.

The company’s Puerto Rico operations will grow from the existing 100 employees to a total of about 400 employees over the next three years.

Romark’s manufacturing facility details

Spanning an area of 35,000ft², the state-of-the-art manufacturing facility produces 500mg Alinia tablets and 100mg/5ml Alinia oral suspension.

It is installed with suites and equipment to manufacture pills, powders, and other types of oral solid dosage forms, expanding Romark’s production and distribution capacity.

The company also acquired an analytical laboratory in Puerto Rico in 2018.

Alinia (nitazoxanide) drug details

Alinia is the only FDA-approved drug to treat diarrhoea caused by both Cryptosporidium parvum and Giardia lamblia in patients aged one year and older.

Oral suspension of Alinia is recommended for patients between one and 11 years, while Alinia tablets are recommended for patients aged 12 years and older.

The most frequent side effects identified for Alinia tablets and oral suspension during clinical trials were stomach pain, chromaturia, nausea, and headache.

Romark’s COVID-19 investigational candidate NT-300 is being tested as a broad-spectrum antiviral medication for the treatment and prevention of viral respiratory diseases caused by common, new, and drug-resistant viruses.

Two phase three clinical trials of NT-300 are underway for evaluating the drug’s potential in the prevention of COVID-19 and management of respiratory diseases induced by rhino and other enteroviruses.

Romark initiated a new phase three clinical study on NT-300 in up to 800 patients for the treatment of mild or moderate COVID-19 in August 2020. The study will measure the recovery time in patients administered with NT-300 compared to placebo.

Financing for Romark’s new manufacturing facility

“The company also acquired an analytical laboratory in Puerto Rico in 2018.”

Stonehenge Capital in partnership with Capital One, Mid-City Community, Empowerment Reinvestment Fund, and HEDC Emerging Markets invested $33m in New Markets Tax Credit (NMTC) financing to complete Romark’s pharmaceutical manufacturing project in October 2018. The investment from NMTC will facilitate the strategic expansion plans of Romark in Puerto Rico.

In the previous phase, Romark invested $46m to rehabilitate, renovate and equip 33,000ft² of vacant space for the development of its products.

Key players involved

Urban Atlantic was responsible for the restoration of the Puerto Rico pharmaceutical facility.

CMA Architects & Engineers, CIC Construction Group, O’Neill & Borges, and Bermúdez-Longo-Díaaz-Masso were involved in the design and construction of the facility.

Other contractors include BLDM, Pharma-Bio Serv, and Pariter Wealth Management Group.

Marketing commentary on Romark

Romark Laboratories is a vertically integrated, multi-national pharmaceutical company based in Tampa, Florida. It focusses on the discovery, development, manufacturing and marketing of new medicines.

The company has presence in Puerto Rico, Belgium, Luxembourg, and Australia. It conducts research and development and handles commercialisation of products worldwide.