The cessation of manufacturing activities follows a Sun Pharma recall and reports that regulators found fault with the company’s quality system.
Sun Pharmaceutical Industries has stopped manufacturing eye-care drugs at a plant in India amid quality concerns.
On an earnings call Friday, Sun Pharma Managing Director Kirti Ganorkar told investors that the company “voluntarily recalled” 11 ophthalmology products and “voluntarily initiated a temporary cessation” of manufacturing activities. However, on the same day, Reuters reported that Indian drug regulators had ordered Sun Pharma to stop manufacturing ophthalmic products at the facility after finding quality management system failures.
Indian regulators reportedly ordered Sun Pharma to shut down its facility in the Indian state of Assam on Aug. 20. The order followed a joint federal-state inspection that identified problems with Sun Pharma’s system for ensuring quality and safety, Reuters said.
Sun Pharma has “taken a remedial action so that we can put everything in place shortly,” Ganorkar said on the earnings call. Indian regulators are reportedly reviewing a compliance report that Sun Pharma submitted in response to the order to stop production.
The company voluntarily recalled 11 ophthalmic products from the Indian market in July. Sun Pharma’s notice lacked an explanation for the recall. However, it later emerged that the All India Ophthalmological Society (AIOS) alerted its members in June about the bacterial contamination of batches of Sun Pharma’s Predmet eye drops.
Multiple ophthalmic institutions found contamination consistent with the presence of Pseudomonas, a pathogen that was responsible for a U.S. eye infection outbreak in 2022 and 2023. In that outbreak, 14 patients who used artificial tears sold by EzriCare and Delsam Pharma suffered vision loss. Indian drugmaker Global Pharma manufactured the EzriCare and Delsam artificial tears.
Sun Pharma has yet to publish a statement about the shutdown, with its public comments limited to a line in the Reuters article and Ganorkar’s response to an analyst’s question on the earnings call. India’s the Bombay Stock Exchange asked Sun Pharma to provide clarification after viewing the Reuters report.
News of the facility shutdown emerged on the same day that Sun Pharma won FDA approval for Ilumya in adults with active psoriatic arthritis. The FDA approved the IL-23 antagonist in plaque psoriasis in 2018. Sun Pharma secured the expanded label after linking Ilumya to reductions in the number of tender and swollen joints in a pair of Phase 3 clinical trials.
The drugmaker reported a slowdown in Ilumya business in the U.S. in the most recent quarter. Sun Pharma executives declined to tell analysts what factors drove the slowdown. Richard Ascroft, the CEO of the company’s North American business, said Sun Pharma has “put key interventions in place already” and expects Ilumya to return to “more typical growth patterns.”
