Nissui Pharmaceutical Co., Ltd.

Change font size

Standard

Large

Site Map

Inquiries

Japanese

Production Plants and Logistics

Nissui Pharmaceutical operates four production plants and a logistics center, making the most of the strengths of each to provide customers with robust quality control and reliable product supplies. Our Diagnostics and Culture Medium Production Plant, in Yuki, has obtained the ISO13485 and ISO9001 international quality management certifications, and our Regenerative Medicine Culture Medium Production Plant makes safe, high-quality products in strict adherence to raw material standards for regenerative medicine products. A beautiful green environment in Tsukuba serves as the home of our Pharmaceutical Production Plant, which is equipped with cutting-edge facilities and, like our Bulk Drug Production Plant, in Kuki, is GMP-compliant. Distribution of the products turned out by these plants is handled by our Supply Chain Management Center.

Diagnostics and Culture Medium Production Plant (Yuki Plant)

ISO・JSA

Nissui Pharmaceutical established the Yuki Plant, a GMP (good-manufacturing practices) compliant pharmaceutical production facility, in 1976. We then added a diagnostics production facility in 1978, an R&D lab in 1982, and a logistics center in 1998, making the Yuki Plant site the central location for some of our most important facilities. Establishment of the Tsukuba Plant took place during two periods – one in 1993 and the other in 1999 - during which pharmaceutical and health food production facilities were built and brought on line. At the same time, the Yuki Plant was reconfigured to focus on extracorporeal diagnostic agents, bacteria and cell culture media, control serums, and other testing products.
By adopting cutting-edge systems and equipment that automate processes and reduce manpower requirements, we are enhancing quality control and building production systems capable of providing high-quality products in line with customer needs. In June 1995, we became the first pharmaceutical company in Japan to obtain the ISO9001 international quality management certification (excluding device products and introducing-devices bearing the name of the manufacturer) for immuno-serological testing agents, one of our main products. In 1999, we obtained ISO9001 certification for all of our diagnostic agent products as part of our effort to build a quality assurance system - one that would cover not only manufacturing but every process, starting at the development stage, and would satisfy global market demands. We followed this effort up by obtaining the ISO13485 international quality management system certification for medical devices (for extracorporeal diagnostic agents only; Registration number: JQA-MD0029) in July 2005 and the ISO14001 international environmental management system certification in March 2006.
To centrally manage information for all of our production plants and sales offices, we have constructed a companywide information network, with the host computer installed at the Yuki Plant.

Facility Overview

Plant Site Area 45,039m²
Manufacturing Floor Space 18,008m²
Production Items Approximately 850 culture media and diagnostics
Address 1075-2 Hokunan-Moro, Yuki-shi, Ibaraki
Telephone: (+81) 296-35-1221
Fax: (+81) 296-35-1217
Transportation Approximately 25 minutes by car or bus from the Koga station of the JR Utsunomiya Line

Facility Overview

Regenerative Medicine Culture Medium Production Plant

Safety is a prime concern for products* used in regenerative medicine. Culture media are essential to the creation of these products and, therefore, must be made in line with rigorous quality standards to deliver the safety required. To meet customer expectations for quality and safety, Nissui Pharmaceutical employs a dedicated facility to produce culture media used for creating regenerative medicine products.

*In the Pharmaceutical Affairs Act, as amended in 2013, regenerative medicine products are defined as a product category apart from pharmaceuticals and medical devices. According to the amended law, a regenerative medicine product is: 1) Human or animal cells subjected to culturing or other processing for use in restoring, repairing, or creating bodily structures or functions, or for use in treating or preventing disease; or 2) A substance introduced into human cells for the purpose of performing gene therapy.

Description

  1. Facility for producing safe, high-quality powdered and liquid culture media in accordance with raw material standards for regenerative medicine products.
  2. Operations conducted under an ISO9001-compliant quality management system.
  3. Manufacturing performed under clean-room-level conditions with strict controls on particles, microorganisms, and other airborne contaminants.

Facility Overview

Name Regenerative Medicine Culture Medium Production Plant
Address 1075-2 Hokunan-Moro, Yuki-shi, Ibaraki
Plant Site Area 37,527m²
Building Area 284m²
Manufacturing Floor Space 282m²
Main Systems and Facilities  Clean booths (Grade A), clean rooms (Grades B, C, D),
hydrogen peroxide decontamination system, stainless steel agitators, ultrapure water system
Production Capacity Powdered culture medium production capacity: 240kg/yr. (Liquid culture medium equivalent = 24,000L)
Liquid culture medium production capacity: 18,000L/yr.

Facility Overview

Bulk Drug Production Plant (Kuki Plant)

Bulk drugs are the active ingredients of pharmaceuticals and must be made in clean manufacturing environments, and to demanding quality standards, equal to those required for finished pharmaceutical products. GMP-compliant operations at our Bulk Drug Production Plant allow us to provide customers with products of outstanding quality.

Facility Overview

Name Bulk Drug Production Plant
Address 13, Shobuchoshowanuma, Kuki-shi, Saitama
Plant Site Area 5,350m²
Manufacturing Floor Space 2,239m²
Production Items Bulk drugs and culture media raw material

Facility Overview

Supply Chain Management Center

ISO・JSA

The Supply Chain Management Center concentrates on conducting logistics operations that respond immediately to market changes. Employing numerous examples of the most up-to-date equipment and systems, this facility has established a logistics system that operates at consistently high levels of quality and efficiency. In achieving its high level of performance, the Supply Chain Management Center has obtained the ISO9001 international quality management certification (excluding device products and introducing-devices bearing the name of the manufacturer), the ISO13485 international quality management system certification for medical devices (for extracorporeal diagnostic agents only; Registration number: JQA-MD0029), and, as of March 2006, the ISO14001 international environmental management system certification.

Facility Overview

Site Area 8,392m²
Floor Space 6,964m²
Items Handled Approximately 2,000
Units Shipped Approximately 500,000 units/year
Address 1075-2 Hokunan-Moro, Yuki-shi, Ibaraki
Telephone: (+81) 296-35-4720 1938
Fax: (+81) 296-35-4722
Transportation Approximately 25 minutes by car or bus from the Koga station of the JR Utsunomiya Line

Facility Overview

Pharmaceutical Production Plant (Tsukuba Plant)NISSUI PHARMA MEDICAL SALES CO.,LTD.

JSA

Aiming to achieve 21st century pharmaceutical production, Nissui Pharmaceutical built a GMP-compliant production plant where we began full-scale production of liquid pharmaceutical preparations in January 1993. Having commenced full-scale production of solid pharmaceutical preparations at the same location in October 1999, we have made this plant into a production center for both pharmaceuticals and health food products.
Striving to enhance the quality of our operations, we obtained the ISO14001 international environmental management system certification in April 2006 .
In our liquid pharmaceutical preparation facility, we have taken steps such as enhancing cleanliness within the plant, introducing a completely sterile filling room, applying filter sterilization, and using ultrapure water to achieve quality well above acceptable levels. At the same time, we have also adopted fully automated production lines, an automated high-rise warehouse, and numerous other cutting-edge systems to achieve outstanding production capacity.
At our solid pharmaceutical preparation facility, our quality-enhancement efforts take place amid temperature and humidity levels kept constant year round. In this facility, we have installed local and central dust collection devices, made clean corridors (from which airflows to individual work areas) even cleaner, and implemented other measures to create a manufacturing environment with robust cross-contamination prevention measures. This facility uses fluid-bed granulation and drying machines; tablet-forming systems capable of unattended night operation; a clean automated warehouse for raw materials, work in process, and intermediate products; various types of filling and sealing machines; and other types of advanced equipment that translate into excellent production capacity for granules, tablets, capsules, semisolids, and granular culture media.
These production facilities are equipped to efficiently turn out products in both large and small lots. We control operations at both facilities by using production management computer systems. These systems are designed to eliminate human error in production planning; and in management of processes, inventories, costs, procurement, weights, quality, and other aspects of manufacturing. Together, these systems and capabilities allow us to efficiently produce, and supply in an on-time fashion, products that excel in both quality and safety.

Facility Overview

Plant Site Area 36,135m²
Manufacturing Floor Space 10,305m²
Production Items Liquid pharmaceuticals preparations Approximately 50 varieties
(Conclevan Levan Royal F, Nissui Seisin Solution and other tonics and nutrients; gastrointestinal medicines; cold medicines; skin care products; health drinks; and other products)
Solid pharmaceuticals preparations Approximately 150 varieties
(Gallol, Gallol Ichou-yaku, and other gastrointestinal medicines; cold medicines; tonics and nutrients; semisolid drugs; health foods; granular culture media; and other products)
Address 1500-12 Muko-Ueno, Chikusei-shi, Ibaraki
Telephone: (+81) 296-52-6111
Fax: (+81) 296-52-6113
Transportation Approximately 30 minutes by car from the Tsukuba station of the Tsukuba Express

Facility Overview