Polaris AI Pharma Achieves Korea’s First Domestic Lurasidone API DMF Registration... Sets Sights on Japanese CNS Market

Polaris AI Pharma has completed registration of the domestically manufactured lurasidone active pharmaceutical ingredient (API) with the Drug Master File (DMF) maintained by the Ministry of Food and Drug Safety, taking steps to enhance the competitiveness of domestic APIs. Having developed its own advanced chiral synthesis technology and completed process validation at commercial production scale, the company plans to expand domestic supply and accelerate its entry into the Japanese central nervous system (CNS) API market.

On August 24, Polaris AI Pharma announced that it had completed DMF registration for its internally developed lurasidone hydrochloride API with the Ministry of Food and Drug Safety. According to the company, this marks the first time that a lurasidone API produced at a domestic manufacturing plant has been registered with the DMF.

Lurasidone is the main ingredient in atypical antipsychotics used to treat schizophrenia and bipolar depression. Due to its multiple stereocenters, the synthesis process must precisely maintain the target stereostructure and meticulously control mirror-image isomers and various process-related impurities. This makes high-level chiral synthesis technology and advanced process control capabilities essential for its production.

Polaris AI Pharma has independently developed the entire manufacturing process for the lurasidone API, from synthesizing the core intermediates to manufacturing the final salt. As part of a phased production scale-up, the company completed process validation (PV) for three 10kg batches, followed by three 100kg batches.

The total impurities in the three 100kg PV batches were in the range of 0.02% to 0.03%, well below the company’s internal limit of 0.50%. Key designated chiral impurities, including mirror-image isomers, were not detected within the prescribed test standards.

The company explained that process reproducibility and quality stability were validated even during scale-up, securing a foundation for implementing advanced chiral synthesis technology at a commercial production level.

With this DMF registration, efforts to enter the Japanese market will now accelerate. Polaris AI Pharma is currently preparing registration with Japan’s Master File (MF) system and is conducting technical evaluations with existing Japanese clients to encourage adoption of its lurasidone API.

The company is supplying evaluation samples and providing technical documentation addressing stability, residual solvents, crystalline form, nitrosamine, and impurity control as required by clients’ test production and quality assessment schedules. However, actual supply will be determined after the clients’ technical and quality evaluations and completion of related procedures, including Japanese MF registration.

Existing partnerships with clients are also considered key to expanding in the Japanese market. Polaris AI Pharma already supplies duloxetine and droxidopa—both CNS APIs—to its Japanese customers. The company’s strategy is to leverage the trust and experience built through these existing products to expand its portfolio to include lurasidone, thereby strengthening its position in the Japanese CNS API market.

In particular, the localization of lurasidone production is regarded as meaningful for diversifying the domestic API supply chain. Currently, lurasidone APIs registered in Korea are mainly produced at overseas manufacturing sites; by securing its own manufacturing capabilities, Polaris AI Pharma has established a domestic supply base for pharmaceutical companies, according to the company.

A representative from Polaris AI Pharma said, “This DMF registration is significant as the first case for domestically manufactured lurasidone API and as the realization of our advanced chiral synthesis technology at commercial scale. Based on the supply experience and quality trust built with our existing Japanese customers, we plan to expand our CNS API portfolio to include lurasidone and strengthen our competitiveness in the global API market.”

Meanwhile, Polaris AI Pharma is also playing a leading role in the localization and process innovation of APIs, having been selected as the lead organization for the “API Purchase Diversification Support Project” led by the Ministry of Health and Welfare. The company also aims to expand both domestic and overseas business by pursuing entry into foreign government procurement markets.

This content was produced with the assistance of AI translation services.