Pharmaceutical distribution company Indies Pharma Jamaica Limited is looking to secure approval from the US Food and Drug Administration (FDA) for at least one, if not both, of its new generic drugs being developed for the US market by the last quarter of 2023.

“We anticipate by or before the end of 2023 to obtain at least one approval from the USFDA,” stated co-founder and chief operations officer (COO) for Indies Pharma Vishnu Muppuri in her remarks published in the company’s recently released annual report.

The company, which has over the last few years made significant investments in research and development (R&D) to ready the two generic drugs, has been deliberate in its steps, as it positions to move into the lucrative US pharmaceutical market valued at over US$730 million per annum. The drugs were successfully developed on the laboratory and commercial scales and done in partnership with US drug maker KP Pharmaceutical Technology Inc.

Up to the first quarter period ended January, the company earned gross revenues of $256 million versus $212 million in the comparable quarter of 2022. This follows improved yearly out-turns of $937 million which it delivered at the end of its 2022 financial year. Net profits for the quarter also increased some 18 per cent to total $59 million while assets moved to $2.2 billion.

Following an $805-million bond attained in 2020 towards “Growth Capital” and to push the development of its two new drugs, total liabilities for the company, however, increased to $1 billion during the quarter. Despite the increase in costs, the company’s directors have indicated that they remain hopeful about the company’s finances and future. The positive anticipation, it said, was also fuelled by the sheer optimistic reports it has received to date concerning the development of the drugs, for which it successfully submitted ANDA (dossier) on January 25, 2023 to the USFDA.

A three-acre property located along the elegant corridor in Ironshore, Montego Bay, which it also acquired from the bond funds in 2020, continues to hold prime value even as it awaits the requisite approvals from the various planning agencies. The $411-million property is to be used for warehousing and commercial activities.

“Indies Pharma remains healthy and solid, having checked all the positive boxes in the respective analytical ratios of liquidity, solvency, profitability, and efficiency. We continue to execute on our strategy through strengthening our intellectual property [new drug development for the US market], tangible assets [prime real estate] and relations with customers, shareholders, and our esteemed employees,” the COO stated in the January quarterly report.

Based in Montego Bay, St James, Indies Pharma services a network over 400 pharmacies, private and public hospitals and government agencies including the National Health Fund, as well as medical practitioners and individual end users. It currently distributes over 150 prescription and non-prescription or ‘over-the-counter’ generic pharmaceutical products for its parent company Bioprist Holdings Limited under the ‘Bioprist Pharmaceuticals’ brand in addition to its new line of products being sold under the orthopaedic and joint rehabilitation segment.