US FDA flags contamination risk for SA-made Aspen eye drops

The US Food and Drug Administration (FDA) has warned Africa’s biggest drugmaker, Aspen Pharmacare, that it breached manufacturing standards for eye drops made at its sterile facility in Gqeberha.

Aspen’s failures put the products at risk of microbial contamination, said the FDA in a letter sent to the company last month.

The Gqeberha site has three units that manufacture sterile products, only one of which makes eye drops. Aspen also makes sterile products at its Notre-Dame-de-Bondeville facility in France. 

Aspen’s eye drops are marketed exclusively in the US and are manufactured under contract for a customer it declined to identify. The export revenue generated by these products is not material to Aspen’s group turnover, said COO Lorraine Hill.

“FDA regulations pertaining to eye drop manufacturing have become more stringent, essentially increasing from an over-the-counter standard to a pharmaceutical injectable manufacturing standard,” she said.

The FDA sent a warning letter to Aspen on February 24, which it published on its website on March 18. It follows an FDA audit last September of the unit at the Gqeberha facility where the eye drops were manufactured, which concluded Aspen had insufficient controls in place to ensure sterile products were not contaminated.

The FDA’s letter, which is partially redacted, says Aspen did not establish scientific systems to monitor impurities during stability testing of products containing the active pharmaceutical ingredients naphazoline hydrochloride or tetrahydrozoline hydrochloride. They are found in nonprescription eye drops used to treat redness caused by minor irritations.

It said FDA inspectors had found levels of impurities — which it did not identify — that might pose a risk to patient safety.

Hill said Aspen had suspended all eye drop manufacturing with effect from September, and the company was working closely with the FDA to address its concerns. Aspen would resume export of the products to the US as soon as it had remediated the FDA’s findings, she said.

JSE-listed Aspen had not disclosed the FDA’s warning to shareholders because the products in question were not material, she said. The JSE requires companies to disclose events or developments that would have a significant effect on performance or earnings.

The Americas region generated R6.7bn (15%) of Aspen’s total group revenue of R44.7bn in the year to June 30 2024. Neither the US nor eye drops are on its lists for its key markets and brands in the region.

kahnt@businesslive.co.za