Polaris AI Pharma registers duloxetine in Korea's DMF, targets domestic market on strength of majority share in Japan

[Financial News] Polaris AI Pharma said on the 11th that it had completed domestic drug master file (DMF) registration for duloxetine hydrochloride (Duloxetine Hydrochloride), for which it holds a majority share of Japan's duloxetine API market. The Korean DMF registration number is '1962-18-ND'.
Duloxetine is the active ingredient in serotonin-norepinephrine reuptake inhibitor (SNRI) medications used to treat depression, generalized anxiety disorder, neuropathic pain and other conditions.
Polaris AI Pharma completed Japan's MF registration for duloxetine hydrochloride in 2019. In 2020, following a related review of finished pharmaceuticals in Japan, it began supplying the API there. The company has maintained supply relationships with major Japanese pharmaceutical companies and secured a majority share of the local duloxetine API market.
A company representative said, “This domestic DMF registration has laid the groundwork for extending into the Korean market our manufacturing technology and quality-control capabilities, which have been validated over many years in Japan,” adding, “We expect our experience meeting Japan's stringent quality requirements to help strengthen the competitiveness of our domestic and overseas API businesses.”
Duloxetine is an API that requires precise control of optical isomers during manufacturing. Polaris AI Pharma has established a high-purity manufacturing process through optical-isomer management throughout the synthesis process and purification technology. No optical isomers were detected in the final API from any of the three process-validation (PV) batches.
Other impurities also met quality standards. In quality tests of three process-validation batches under European Pharmacopoeia (EP) standards, both specified and unknown impurities were found at levels of 0.05% or less, considered negligible under the analytical method. The company said, “These control technologies have provided the basis for maintaining a stable supply and high market share in Japan.”
The company also has a control system in place for nitrosamine-related impurities, which have recently emerged as a key challenge in pharmaceutical quality management. Duloxetine is a product that requires control of NDLX, a nitrosamine impurity. Tests conducted by the company on three process-validation batches found that all were within the established control limits. The company also has experience addressing regulatory requirements during reviews by Japan's Pharmaceuticals and Medical Devices Agency (PMDA), drawing on technical documentation and quality assessment materials related to nitrosamines.
This registration follows the company's domestic DMF registration for lurasidone hydrochloride last August. Polaris AI Pharma is strengthening its capabilities in developing high-value-added APIs, including by independently developing the lurasidone manufacturing process using advanced chiral synthesis technology and completing process validation for commercialization.
A Polaris AI Pharma representative said, “We have completed domestic DMF registration based on manufacturing technology and quality-control capabilities validated in the Japanese market,” adding, “Alongside expanding in the Korean market, we will continue to strengthen our global competitiveness in the CNS API sector.”
Meanwhile, Polaris AI Pharma is preparing to register lurasidone hydrochloride with Japan's Master File (MF) while working to expand its local CNS API portfolio. It was also selected as the lead institution for the Ministry of Health and Welfare's “Raw Material Procurement Diversification Support Program” and is pursuing the localization of raw materials and process innovation, as well as entry into overseas government procurement markets.
[email protected] Choi Doo-seon Reporter