Our Strategic Expansion in Japan: Reinforcing Production to 2 billion tablets and aiming to be the “Most Trusted CDMO”

by Azul Gonnet · April 8, 2024

Adragos Pharma is actively pursuing contract manufacturing in the Japanese market.  Leveraging ex-Sanofi’s Kawagoe plant (located Kawagoe City, Saitama Prefecture) which they acquired one year ago as their flagship manufacturing site, they are reinvesting on solid dosage manufacturing to serve a production capacity of 500 million tablets, with a scheduled increase to meet the anticipated demand of 2 billion tablets in the future.  Furthermore, they are targeting the bio-pharmaceutical sector, which is expected to experience increased demand due to foreign bio-pharmas listings in the Japanese market.  Their site aims to capture visual inspection and secondary packaging outsourcing demand, leveraging their existing capability.  As a foreign affiliated company, they also utilize their English communication skills.  Their mission is to become the “Most Trusted CDMO.”

Adragos Pharma is a globally operating CDMO headquartered in Germany founded in 2020.  The company has been expanding its production network through acquisitions and it currently operates manufacturing sites in Germany, France, Greece and Norway.  Notably, Adragos Pharma has taken significant steps in the Japanese market by acquiring the Kawagoe site in March of last year.  Adragos Pharma’s services are supported by strong track records in manufacturing small molecule solid preparations, as well as various dosage forms. The reason for strengthening the business in Japan is that they anticipate there is still room to utilize CDMO services as it boasts the world’s third largest (pharmaceutical) market size and pharmaceuticals will play a crucial role in the aging population.  The company aims to contribute through meeting high-quality manufacturing standards and providing stable supply.

President Keizo Yanagisawa stated, “Our business has progressed seamlessly, surpassing our initial goals. Moving into the second year and beyond, we will further enhance the manufacturing capacity of the Kawagoe plant, primarily focusing on solid formulations, to meet (growing) demands.  Additionally, we have our sights set on bio-pharmaceuticals.  Our commitment is to supply foreign pharmaceutical companies, including bio-pharmas entering Japan, with the high-quality standards required in the Japanese market.  We anticipate an increased demand for inspection and packaging of injectables, and our company is well-prepared to provide the necessary support.”

Hideyuki Tanaka, Head Commercial U.S. & APAC of Global Sales, expressed that they successfully secured multiple contracts with approximately 500 million solid tablets and emphasized about his experience, “Despite supply uncertainties, we not only excel in manufacturing high-quality products, but also our unwavering confidence in expanding our production capacity in the future offers reassurance from a business continuity planning (BCP) standpoint.” 

In addition to manufacturing solid dosage forms, the Kawagoe site boasts capabilities to inspect and package 1.5 to 2 billion tablets, making it capable of integrated manufacturing.  It also has the capacity to inspect and package 15 to 20 million injectables, still about half of its capacity available.  For imported sterile preparations, such as vaccines, the site is equipped with inspection and packaging capacity for approximately 4 million cases.  The company aims to increase its solid dosage manufacturing capacity to 1 billion tablets by mid-2025 and it has its sights set on expanding production capacity to 2 billion tablets in the not so distant future.

In the face of many competitors, Masanori Kurogome, site head of Kawagoe explains the appeal of the Kawagoe site as follows.

“We possess (exceptional) human capital and (state-of-the-art) facilities, complemented by robust support systems.  Our organization fosters a pervasive culture of high quality and safety standards. The Kawagoe site, with its ample land, is highly expandable.  We can readily add equipment and scale up capacity as needed.  Having served as a manufacturing hub for a global pharmaceutical over an extended period, our systems, procedures, education and training programs are meticulously designed to uphold stringent quality and safety norms.  This commitment is deeply ingrained in our daily practices and site culture.  Moreover, a substantial portion of our personnel is proficient in English communication.  I believe this talent serves as a compelling incentive for foreign pharmaceutical companies seeking to expand their operations in Japan as effective communication during projects and seamless technology transfers are key advantages we offer.”

Adragos Pharma aims to anticipate and meet the growing demands resulting from the expansion of foreign bio-pharmas, particularly those specializing in orphan drug development into the Japanese market.

President Yanagisawa talked about his aspirations, “Our goal is to establish the robust site capable of fully addressing our customers’ needs in terms of quality.  We strive to grow as a CDMO that consistently produces and supplies high-quality products, thereby continuously satisfying our (valued) customers. “

Read the complete article in Japanese here: https://www.yakuji.co.jp/entry108961.html



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