Janssen Korea’s pain reliever Ultracet has been confirmed to be excluded from the Ministry of Food and Drug Safety’s (MFDS) comprehensive investigation into tramadol-related impurities. Industry officials attribute this outcome to the company’s preemptive quality management and strategic sourcing policies.

A Janssen Korea representative stated on October 17, “Ultracet has not been subject to any recall orders recently issued by the MFDS,” adding that the company “has also not received any data submission requests regarding re-verification of impurities in Ultracet distributed in Korea.”

This stands in contrast to several South Korean pharmaceutical firms that were asked to re-verify their tramadol + acetaminophen combination products as part of the MFDS’s nationwide impurity review. While many companies have submitted new test data to the regulator, Janssen’s product was not among those subject to additional scrutiny.

Industry sources say this likely stems from Janssen’s long-standing policy of excluding Indian-sourced tramadol ingredients from its Ultracet supply chain, effectively minimizing contamination risks. “Janssen adopted an internal policy years ago to avoid Indian raw materials for its tramadol products,” one source explained, noting that some Indian API producers “have repeatedly failed to meet global GMP standards.”

The Indian manufacturer at the center of the impurity issue—known as “Company A”—is a major contract supplier of tramadol APIs to many Korean drugmakers. However, it received warning letters from the U.S. FDA in both 2023 and 2024, following critical observations during inspections. The June 2024 letter cited “serious violations of current Good Manufacturing Practice (cGMP) regulations,” including inadequate cleaning, poor supervision, and weak quality-control oversight. The FDA warned that continued non-compliance could lead to import restrictions on the firm’s APIs.

Experts believe Janssen likely conducted independent audits of Indian suppliers long before the MFDS review. “The FDA only issues warning letters when violations are serious,” said a quality-management executive at a mid-sized pharmaceutical company. “Given Ultracet’s brand reputation, Janssen would have verified all tramadol sources thoroughly to prevent any quality issues.”

According to UBIST data, Ultracet recorded $11.4 million in prescription sales during the first half of 2025, leading Korea’s $54.5 million tramadol + acetaminophen market. Despite competition from 286 generic products, Ultracet maintains the top market share.

A quality-assurance manager at a South Korean API supplier noted that while Korean companies recognize the risks of India-made raw materials, many rely on them to reduce costs amid intense price competition. “Janssen, as the original developer of tramadol products, has extensive expertise in raw-material verification and a globally aligned GMP system,” the manager said. “This foundation allowed the company to navigate the MFDS impurity review without difficulty.”