[Edaily Reporter Yoo Jin-hee] Dasan Pharmaceutical has successfully completed an on-site inspection by Japan’s Pharmaceutical and Medical Devices Agency (PMDA), accelerating its efforts to penetrate the local market and expand its global Contract Development and Manufacturing Organization (CDMO) business.

Countdown to Strict Japanese PMDA Approval... Securing Global Credibility

According to the pharmaceutical industry on the 29th, Dasan Pharmaceutical has recently completed a PMDA on-site inspection at its Asan plant in South Chungcheong Province and is awaiting final approval notification. Approval is expected by June at the latest.

The PMDA, an agency under Japan’s Ministry of Health, Labour and Welfare (MHLW), oversees the licensing, review, and post-marketing safety management of pharmaceuticals and medical devices, as well as Good Manufacturing Practice (GMP) inspections of manufacturing facilities. The PMDA is recognized as one of the world’s top regulatory agencies, alongside the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In particular, the PMDA is known for applying very conservative standards regarding data integrity and quality criteria.

Even within South Korea, it is extremely rare for a company to receive a compliance determination for finished pharmaceutical products through a PMDA inspection. As of 2024, it is reported that only four out of the 17 domestic companies that received a compliance determination are manufacturers of finished pharmaceutical products. This means that if Dasan Pharmaceutical obtains this approval, it will serve as an indicator that the company’s quality management capabilities have been officially recognized as being at a global level.

After receiving notification of the inspection in late January, Dasan Pharmaceutical underwent approximately two months of preparatory checks and then underwent a four-day on-site inspection from March 10 to 13. This inspection served as an on-site verification following the 2021 written review approval, during which Japanese regulatory inspectors reportedly conducted a thorough review of the special formulation production lines and the overall quality system.

Once this approval is finalized, Dasan Pharmaceutical will not only expand sales of Duloxetine Hydrochloride Pellets but also secure the quality requirements necessary for the official launch of Venlafaxine Pellets in Japan next year.

Duloxetine and venlafaxine, the focus of this inspection, both embody Dasan Pharmaceutical’s advanced pellet manufacturing technology. A pellet is a dosage form in which a drug is coated onto fine spherical particles. Release control technology, which regulates the slow release of the drug over a specific period within the body, is considered an essential element. Dasan Pharmaceutical is recognized for its stable quality reproducibility in areas requiring high-precision control, based on its differentiated competitive strengths such as fluidized-bed coating technology.

Duloxetine hydrochloride pellets are used to treat depression, generalized anxiety disorder, and diabetic peripheral neuropathic pain. They feature an enteric coating technology that prevents the drug from being broken down by stomach acid and ensures absorption in the intestines, thereby enhancing both patient convenience and therapeutic efficacy. Venlafaxine pellets contain a representative antidepressant and anxiolytic ingredient. Given the need to maintain a consistent blood concentration of the drug, advanced sustained-release coating technology is required.

The direct outcome of this successful inspection is the strengthening of the Central Nervous System (CNS) therapeutic portfolio. It is viewed as having solidified the sales foundation by renewing the GMP certification for the existing duloxetine hydrochloride pellets, while simultaneously laying the groundwork for the entry of the next-generation product, venlafaxine pellets, into the Japanese market.

A Dasan Pharmaceutical official stated, “This is significant because we have established a quality system that meets PMDA standards for highly complex CNS specialty formulations,” adding, “Starting with this inspection, we plan to fully expand our CDMO business targeting global pharmaceutical companies beyond the Japanese market.”

Collaboration with Japan’s CNS leader ‘Kyowa’... Momentum for Benlapaxine Launch Next Year

Dasan Pharmaceutical did not rest on its laurels even during the COVID-19 pandemic, upgrading its production facilities to meet U.S. (cGMP) and European (EU-GMP) standards. The company operated a company-wide response team to ensure data integrity. Since Japanese pharmaceutical companies consider PMDA inspection history to be the most important criterion when selecting overseas manufacturing sites, this result is expected to serve as a powerful asset in securing new clients.

The company has already secured clients. Dasan Pharmaceutical has established a solid partnership with Kyowa Pharmaceutical Co., Ltd., a major player in Japan’s central nervous system (CNS) market. Founded in 1954, Kyowa possesses a strong sales network in Japan through its CNS-specialized brand, AMEL. The revenue growth resulting from this approval is predicted to be a key driver of increased corporate value.

In particular, if the approval results are announced by the end of this month, pellet supply will begin next month, and sales related to venlafaxine will be fully reflected in the company’s financial statements starting next year. As Dasan Pharmaceutical is preparing for an IPO in the second half of this year, these prospects for improved performance are expected to attract significant interest from investors.

In fact, Dasan Pharmaceutical is continuing its rapid growth. Revenue, which stood at 51.9 billion won in 2021, doubled to 106.9 billion won last year—a twofold increase in just four years. This growth trend is expected to accelerate further as new businesses, such as CDMO, expand. The company is also signaling a successful IPO based on this momentum. This is evidenced by the successful raising of 13 billion won in a pre-IPO round last December, in which KB Securities and NH Investment & Securities participated.

A Dasan Pharmaceutical official stated, “We will use the funds secured through the IPO to expand production facilities, launch new products, and strengthen our CDMO competitiveness,” adding, “We will maintain our momentum for sustained growth even after the IPO.”