Alfresa Pharma Co., Ltd. (Headquarters: Osaka; Representative Director, President and Executive Officer: Shori Araki; hereinafter "Alfresa Pharma"), a subsidiary of our company engaged in the manufacturing of pharmaceuticals and other products, announced today that its new pharmaceutical manufacturing building at the Gunma Plant has commenced operations, as detailed below.
Note
1. Background and Purpose The Alfresa Group positions its Total Supply Chain Service (TSCS*4) as a pillar of its business strategy, which involves the group working as one to provide services from the introduction and development of pharmaceuticals, manufacturing, logistics and sales, to post-marketing surveillance (PMS*3) and last-mile delivery, under its growth strategy "Alfresa Group Mid-to-Long Term Vision"*1 through FY2032 and the "25-27 Mid-Term Management Plan Vision2032 Stage2 ~Pioneering the Future with Comprehensive Strength~"*2. Furthermore, leveraging the functions of TSCS, we have launched "PATH-Solution" (trademark pending), a platform that comprehensively supports entry into the Japanese market, aiming to remove barriers for overseas emerging biopharmaceutical companies entering Japan and enable speedy market entry*5.
In addition to manufacturing and selling pharmaceuticals, and manufacturing, importing/exporting, and selling diagnostic reagents, medical devices, and pharmaceutical raw materials, Alfresa Pharma has been actively engaged in contract manufacturing of pharmaceuticals and quasi-drugs since 2009, following the revision of the Pharmaceutical Affairs Law in 2005, which allowed for full outsourcing of pharmaceutical manufacturing. As one of its initiatives in growth areas, the company has aimed to expand contract manufacturing and build a more efficient and high-quality manufacturing system, proceeding with the construction of a new pharmaceutical manufacturing building since 2024*6.
The operation of this new building will strengthen the production system for low-molecular-weight drugs and enable full-scale entry into contract manufacturing of highly potent drugs*7 and contract inspection, packaging, and testing of sterile preparations*8. This will further evolve and expand the development-to-manufacturing functions within our group's TSCS, solidifying our system to deliver diverse modalities of pharmaceuticals with "safety," "security," and "integrity" to medical institutions and patients who need them.
*1 Reference: Announced on May 15, 2023 Announcement of "Alfresa Group Mid-to-Long Term Vision" https://ssl4.eir-parts.net/doc/2784/tdnet/2281689/00.pdf
*2 Reference: Announced on May 15, 2025 Announcement of "25-27 Mid-Term Management Plan Vision2032 Stage2 ~Pioneering the Future with Comprehensive Strength~" https://ssl4.eir-parts.net/doc/2784/ir_material21/256657/00.pdf
*3 PMS: (Post Marketing Surveillance) Surveys conducted after pharmaceuticals and medical devices are sold to ensure quality, efficacy, and safety.
*4 TSCS: Refers to the Alfresa Group's integrated provision of various functions, from the introduction and development of pharmaceuticals, manufacturing, logistics and sales, to post-marketing surveillance and last-mile delivery, by organically utilizing all functions held by the entire Alfresa Group to establish a seamless supply chain.
*5 Reference: Announced on January 30, 2026 Announcement of "PATH-Solution" Service Launch, a platform to support overseas emerging biopharmaceutical companies entering Japan to resolve "drug lag/loss" https://ssl4.eir-parts.net/doc/2784/ir_material15/272407/00.pdf
*6 The construction of this new building is one of the uses of funds procured through social bonds, which obtained a second-party opinion from an external evaluation institution based on the "Social Bond Framework" formulated by our company, and is positioned as an initiative contributing to the resolution of social issues. (Reference: Announced on November 7, 2023, "Announcement Regarding Issuance of Social Bonds") https://ssl4.eir-parts.net/doc/2784/tdnet/2355084/00.pdf
*7 Highly potent drugs: Pharmaceuticals containing ingredients that exert strong pharmacological effects on the human body in small amounts, requiring special equipment and procedures for safe handling and manufacturing.
*8 Sterile preparations: Pharmaceuticals guaranteed to be free of viable microorganisms. Examples include vial preparations, ampoule preparations, and syringe preparations used as injectables.
2. Overview of the New Pharmaceutical Manufacturing Building [Image]
3. Future Outlook At the new pharmaceutical manufacturing building at the Gunma Plant, we aim to commence commercial production at an early stage after undergoing PQ*9 and PV*10. While the impact of this matter on the current fiscal year's performance is expected to be minor, we believe it will contribute to enhancing our group's corporate value in the medium to long term.
Should any matters requiring disclosure arise regarding this issue in the future, we will promptly make an announcement.
*9 PQ: (Performance Qualification) Qualification assessment to confirm that equipment performs its approved functions under actual manufacturing conditions.
*10 PV: (Process Validation) Activities to scientifically and documentarily verify that a manufacturing process consistently meets quality standards.
[Contact for this matter] Alfresa Pharma Supply Chain Division, Contract Business Management Department, Contract Sales Department (TEL: 0276-52-6032 E-mail: info@alfresa-pharma.co.jp)
[Image] <Alfresa Pharma Gunma Plant's New Pharmaceutical Manufacturing Building>
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- Source: PR TIMES
- Category: News