PolarisAI Pharma registers domestically produced lurasidone DMF, targets Japanese market

[Financial News] PolarisAI Pharma has completed the Drug Master File (DMF) registration with the Ministry of Food and Drug Safety for the active pharmaceutical ingredient (API) of lurasidone hydrochloride, which it developed in-house.
According to PolarisAI Pharma on the 24th, this is the first time a lurasidone API produced at a domestic manufacturing site has been registered with the Ministry of Food and Drug Safety's DMF. The company said it has secured a domestic supply base through in-house development and production, even as existing registered products in Korea have mainly been made at overseas facilities.
Lurasidone is the main ingredient in atypical antipsychotics used to treat schizophrenia and bipolar depression. Because the molecule has multiple stereocenters, its synthesis requires chiral synthesis technology that can preserve the target stereochemical structure while controlling enantiomers and process-related impurities.
PolarisAI Pharma developed the entire manufacturing process in-house, from synthesizing key intermediates to producing the final salt. It then completed Process Validation (PV) for three 10-kilogram batches and three 100-kilogram batches, laying the groundwork for commercial production.
A PolarisAI official said, "In the three 100-kilogram PV batches, total impurities were 0.02% to 0.03%, meeting our internal standard of 0.50% or less." The official added, "Chiral impurities such as enantiomers and major specified impurities were also not detected under the test criteria. We confirmed process reproducibility and quality stability even as production scale increased."
PolarisAI Pharma plans to expand domestic supply through this DMF registration while also accelerating its entry into Japan's central nervous system (CNS) API market. The company is currently preparing registration in the Japanese MF registry and is conducting technical evaluations with existing Japanese clients for lurasidone adoption. In addition to supplying evaluation samples, it is also providing technical documents required for Japanese registration, including data on stability, residual solvents, crystal form, nitrosamines and impurity control. Whether actual supply will proceed will be decided after the client's technical and quality review and related procedures, including MF registration in Japan.
PolarisAI Pharma supplies CNS APIs such as Duloxetine and Droxidopa to the same Japanese client. A company official said, "This DMF registration is significant as the first case of a domestically manufactured lurasidone API being registered and as proof that our advanced chiral synthesis technology has been implemented at commercial production scale." The official added, "Based on the supply experience and quality trust we have built with our existing Japanese client, we will expand our CNS API portfolio."
Meanwhile, PolarisAI Pharma has been selected as the lead organization for the Ministry of Health and Welfare's raw material procurement diversification support project, and is pushing to expand its business at home and abroad, including entry into overseas government procurement markets.

[email protected] Choi Du-seon Reporter