Two new generics approved by FDA

Durrant Pate/ Contributor

Montego-based pharmaceutical company Indies Pharma has successfully submitted its Abbreviated New Drug Applications (ANDA) to the United States Food and Drug Administration (FDA).

The applications relate to two generic pharmaceutical drugs being developed by the company, through an agreement with KP Pharmaceutical Technology Inc, and which were seeking the FDA’s approval for entry into the US market.

The two drugs, which have now received the FDA’s approval, were successfully developed on the laboratory and commercial scales.

ANDA APPROVAL TO BENEFIT COMPANY, SHAREHOLDERS

Speaking with Our Today, Dr Guna Muppuri, Indies Pharma president and CEO, said the company did not intend to utilise third party licences to manufacture the new drugs in other countries but intended to bring the production in-house.

According to Muppuri, the successful ANDA approval will open the US pharmaceutical market, valued at US$730 billion per year, to the two Indies Pharma drugs.

With this in mind, he added that the successful ANDA approval is expected to be beneficial to the company and, by extension, shareholders.

Muppuri is optimistic of the company’s future given this latest development.

In 2020, Indies Pharma secured a loan facility in the amount of J$805 million by way of a private placement bond from Sagicor Investments for two purposes, one of which was to provide funding to develop and get approval for the ANDA applications.

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. The company distributes more than 150 prescription and non-prescription (or ‘over the counter’) generic pharmaceutical products.