Contract Development and Manufacturing
(CDMO) Business

Nagase Medicals focuses on CDMO business centered on sterile pharmaceutical manufacturing technologies. These include highly potent pharmaceutical products such as anti-cancer drugs. Our service has been used by major Japanese and foreign pharmaceutical companies and we obtain customer’s trust.
We provide services tailored to your various needs for contract development and manufacturing. Each department will work closely and give their total support to your products from formulation and design of the dosage form to investigational drug manufacturing, application for approval, validation and full-scale production. We also provide prototyping or small-lot production at the development stage or in clinical trials, and are establishing a system that will meet the PIC/S GMP standards.

CDMO Process

We can flexibly respond to your requests.
For any enquiries regarding the CDMO business, please contact us here.

Flow of the CDMO (example)

受託の流れ 受託の流れ

Production System

As well as regular maintenance and inspection of the production line, we set up a 40-day shutdown period each year for maintenance, repairs and renewal of the equipment to ensure effective and stable operations, and maintain manufacturing management system standards.
For traditional pharmaceutical products, an automated rack-type warehouse was built and connected to the general pharmaceutical products building (Pharmaceuticals Building). By streamlining logistical operations through functional layout, extending the product warehouse and utilizing the NAGASE Group’s distribution warehouses, we have established a system for providing comprehensive manufacturing services. For highly potent pharmaceutical products, the highly potent product manufacturing building (No. 2 Injectables Building) has a raw material and product storage room and all manufacturing processes from raw material storage to product shipment can be completed within the building. It also offers a containment function as a manufacturing facility for anti-cancer drugs.
In addition, we invest in personnel training and utilization to further improve quality and efficiency. Each employee has high motivation and knowledge of quality and costs, leading to a number of technical improvements in the production line.
We also received ISO14001 certification in April 2006 and are striving to reduce our environmental impact in both production and distribution.

ISO

Quality Assurance System

Nagase Medicals operates a quality system based on ICH Q10 at all stages of production from selection of raw materials at the development stage through manufacturing and shipping. We have established manufacturing and quality management systems, which are required for globalization, such as PIC/S GMP.
Our quality control department also has dedicated weighing and preparation booths to conduct product quality testing and acceptance testing of materials for highly potent pharmaceutical products.

品質保証体制