Approval comes earlier than the expected November date

Durrant Pate/ Contributor

Montego Bay-based pharmaceutical company, Indies Pharma Jamaica has created history in becoming the very first Jamaican company to receive the US Food and Drug Administration (USFDA) approvals for an abbreviated new drug application (ANDA) or generic drug.

The USFDA gave its stamp of approval on August 22, 2024 with respect to the generic drug, Regadenoson Injection, 0.4 mg/5 mL, the application for which was submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FE&C Act) on January 25, 2023.

The USFDA determined that Indies Pharma’s “Regadenoson” is bioequivalent and therapeutically equivalent to Astellas Pharma US, Inc’s Lexiscan^® (Regadenoson Injection). Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress.

Most anticipated drug approval 

A portion of Indies Pharma’s J$805 million bond underwritten by Sagicor Investments was used to develop this drug to gain entry into the US market. The Dr Guna Muppuri-led company says this is one of the most anticipated drug approvals with the expected USFDA approval date being in November 2024 but has arrived earlier than expected. 

ANDA approval will open the US pharmaceutical market, valued at US$730 billion per year, to the two Indies Pharma drugs and will be beneficial to the company and, by extension, shareholders. Dr Muppuri is optimistic of the company’s future given this latest development telling Our Today in an interview in February last year that the company has no intention to utilize third-party licences to manufacture the new drug in other countries but intended to bring the production in-house.

Indies Pharma, which is headquartered in a commercial complex in Freeport, Montego Bay, currently services customers across all 14 parishes including more than 400 pharmacies, private and public hospitals and government agencies such as the National Health Fund. It distributes more than 150 prescription and non-prescription (or ‘over the counter’) generic pharmaceutical products.