Production System

Our most advanced manufacturing system ensures providing high quality products.

We manufacture high-quality pharmaceutical products and medical devices at our four production sites:
the Okayama plant and the Gunma plant, which complies with the GMP requirements, the Chiba plant which produces a wide range of medical devices in accordance with the QMS ministry ordinance, and the Qingdao Nesco Medical Co., Ltd., which is our Asian production base for surgical sutures. All these plants, putting their priority on high-quality and stable supply of the products, work to further expand their facilities and continue to take on the challenge of improving cost performance and productivity to fulfill the trust and expectations of our customers.

  • Okayama Plant

    High production capacity in pharmaceuticals and diagnostic reagents, from manufacturing of liquid/solid formulations to the packaging process

    -Pharmaceuticals GMP compliance *1
    -ISO13485 certification *2

    *1 GMP (Good Manufacturing Practice): Manufacturing and quality control of pharmaceuticals, etc.
    *2 ISO13485: International standard for quality management systems for medical devices.

  • High production capacity of pharmaceuticals and diagnostic reagents from liquid/solid formulations to the packaging process

    We manufacture high quality products in a strict manufacturing and quality control system which is established in conformity with the GMP requirements *1 for pharmaceutical products, and with the international quality management system ISO 13485 *2 for diagnostic reagents. In addition to conducting repeated quality tests at each step to determine if a product is ready to be shipped, we also conduct stability testing after shipment of the products. We have succeeded in mass production of immune reagents, and possess solution facilities which enable aseptic manipulation manufacturing.

    At our Okayama plant we aim to further strengthen the manufacturing capacity of high-quality pharmaceutical products, and our manufactu-ring facility for liquid/solid formulations has been in full-scale operation since 2009. In addition to establishing a quality management system to monitor the production line from every different angle, and fully furnishing a clean manufacturing environment to produce the liquid products, we have installed state-of-the-art equipments that are able to meet a variety of needs in producing high quality products.

  • Gunma Plant

    -Contract manufacturing*3
    -PIC/S GMP*4
    -ISO 14001 certification*5

    *3 Contract manufacturing: Manufacturing products by taking on all or part of the manufacturing process from a contractor.
    *4 PIC/S GMP: Manufacturing control and quality control of pharmaceuticals, etc.
    *5 ISO 14001 certification: International standard for environmental management systems.

Contract manufacturing of a wide variety of products with a commitment to quality

Based on its technological capabilities cultivated over many years, the Gunma Plant manufactures ethical and over-the-counter pharmaceuticals and quasi drugs as well as food additives and investigational drugs on a contract basis. Dosage forms include tablets (sugar-coated, film-coated, wet tablets®, etc.) and capsules, as well as granules, dispersions, liquids, and ointments (creams). Packaging formats include PTP (blister packaging), double-sided aluminum PTP packaging, sachets, bottle packaging (polyethylene containers and glass bottles), tube packaging, double-formed packaging, and many others.

Our employees are conscious of “creating quality” with the aim to produce a stable supply of high-quality products while using facilities, equipment, environments, and systems compliant with PIC/S GMP to strictly control quality and manufacturing, from the receipt of raw packaging materials to inspection and shipment of final products.

In recent years, new equipment has been installed to prepare for increased production volumes. In 2019, a special high-voltage substation was installed to receive 10 times more voltage than before. We also added a warehouse to increase our storage capacity by 1.3 times. Furthermore, we are striving to further improve quality assurance and manufacturing management by introducing a laboratory information management system (LIMS) in 2020 and a manufacturing execution system (MES) in 2022.

The Gunma Plant possesses formulation and packaging technologies suitable for a wide variety of dosage forms and packaging formats. We will continue to train high-quality engineers, actively utilize new technologies to achieve technological development and industrialization, and earnestly respond to the various requests of our contractors. Moreover, in cooperation with other Alfresa Group companies, we will provide seamless supply services from development and manufacturing to distribution and sales.

In addition, the Gunma Plant has obtained ISO 14001 certification, the international standard for environmental management systems.

We utilize a central energy monitoring and control system to comprehensively manage energy in the plant. In addition, impurities are removed from tap water using a dedicated purification system, and after being used for manufacturing as purified water, it is decomposed by microorganisms and discharged in a clean water state. We will continue our efforts to conserve energy and protect the environment. Furthermore, we will fulfill our social responsibility through various community contribution activities and contribute to the realization of a sustainable society as a good corporate citizen.

  • Chiba Plant

    The largest surgical suture manufacture, and our production base for various types of medical devices

    -Medical devices QMS *6 compliance
    -ISO13485 certification
    -CE marking *7 certification

    *6 QMS (Quality Management System): Management system to ensure the quality of products and services.
    *7 CE Marking: Mark indicating that the products comply with the safety standards of the European Union (EU).

  • The largest surgical suture manufacture, and our production base for various types of medical devices

    Our Chiba plant, with state-of-the-art facilities, is the largest surgical suture manufacturing plant in Japan. It is equipped with integrated systems for the technological development and manufacturing of a variety of medical devices focused on surgical sutures (NESCO sutures), and functional products which are safe and easy to use. We have built a strict quality management system based on the QMS criteria, covering all processes from the arrival of raw materials to manufacturing, packaging, and shipping. In addition, we have enhanced our state-of-the-art testing facilities and conduct tests at four different stages: receiving, in-process, intermediate products, and finished products. Our in-house standards are stricter than the Pharmaceutical Affairs Law and Government standards, and we ship only products which have passed our internal standards out to the market.

  • Qingdao Nesco Medical Co., Ltd.

    The stable supply of high-quality surgical sutures from our Asian manufacturing base

    -Medical devices QMS compliance
    -ISO13485,ISO9001 certification

  • The stable supply of high-quality surgical sutures from our Asian manufacturing base

    Qingdao Nesco Medical Co., Ltd. is our manufacturing base in Asia and is located in the economic development zone of Qingdao City, which is at approximately midway between Beijing and Shanghai. In addition that we produce high quality silk sutures taking advantage of its favorable geographic location for securing abundant high-quality raw silk, we also produce synthetic absorbable sutures and cardiovascular surgical sutures utilizing same level of manufacturing technology as we have in Japan.

    We have established a high leveled quality control system and have organized a strong sales team in order to expand our sales in global market, mainly in China and Asian countries.