Durrant Pate/Contributor

Montego Bay-based pharmaceutical company, Indies Pharma, will be releasing for the first time three new products, which are prescription drugs developed by its parent company, Bioprist Group.

The Bioprist-branded generic prescription drugs are Biocept, Herpox and Itronox. They will be made available in seven stock-keeping units (SKUs). In the case of Biocept (Mycophenolate Mofetile), the drug is being made available in 250mg and 500mg.

Indies Pharma has pioneered in bringing the first of this generic option, now being made available for the Jamaican people.

Mycophenolate is used with other medications to help prevent transplant organ rejection (attack of the transplanted organ by the immune system of the person receiving the organ) in adults and children three years of age and older, who have received kidney, heart or liver transplants.

The other two prescription generic drugs, Herpox tablets in 200mg, 400mg and 800mg and the cream (Acyclovir), targeting the treatment of chicken pox and other Herpes infections, and Itronox 100 (Itraconazole 100mg) broad spectrum antifungal antibiotic.

ANDA application

In the meantime, Indies Pharma successfully submitted its very first Abbreviated New Drug Application (ANDA), a generic drug dossier, in January 2023 at the US Food and Drug Administration (FDA). The same was accepted by the FDA without any rejections or queries on February 24 with a gold date of approval as November 2023.

The product filed at the FDA is a patent challenge under the paragraph IV filing, which has now been accepted and gone unopposed by the innovator drug company on the United States market. This is an incredible development that is destined to reap the benefits for Indies Pharma from the US market in the immediate short future.