Our Plants

Production system and
Commitment to the
creation of value

A high-level production setup that
meets global standards

We have worked to enhance GMP*, which is a quality assurance standard, and, while working to maintain and improve various quality systems, we have established measures to address PIC/S** aimed at achieving global harmonization of GMP standards.
We have built a system to supply products not only inside Japan, but also to other countries.

Measures to ensure thorough quality
control and EHS activities

We have implemented acceptance tests and evaluations of raw materials in compliance with GMP and conduct rigorous manufacturing and quality management for each process. In terms of the environment and occupational health and safety, we vigorously promote EHS activities and endeavor to enhance the level of health and safety, aiming to reduce labor-related accidents and disasters to zero.

*Good Manufacturing Practice **Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme

Noshiro Plant

Established: 1995
Site area: 104,422ｍ²

Items manufactured: Prescription drugs (solid dosage forms)
Certifications obtained: ISO14001
（Environmental management system）
Obtained in 2001; OHSAS18001
（Occupational health and safety management system）
Obtained in 2003; ISO45001
（Occupational health and safety management system）
Obtained in 2019

Low-cost, high-volume manufacturing. Integrated manufacturing from active pharmaceutical ingredients to finished products.: The Noshiro Plant began operations as the pharmaceutical manufacturing plant of KYORIN Pharmaceutical, and is engaged in API (Active Pharmaceutical Ingredients) manufacturing of products developed in-house. Subsequently, as a manufacturing plant of finished products, automated transport of pharmaceutical ingredients and intermediate products, and robotic arms for labor saving have been introduced. Automation makes it possible to manufacture large volumes at a low cost with high productivity. Using these strengths, the facility has recently begun manufacturing generic drugs in large volumes in addition to new drugs, focusing on tablets and capsules. The plant has also achieved solid success in inspections by overseas regulatory authorities.

Inami Plant

Established: 1975
Site area: 12,966.5ｍ²

Items manufactured: Prescription drugs (solid dosage forms, injections, eye drops) and OTC drugs (eye drops)
Certifications obtained: ISO14001
（Environmental management system）
Obtained in 2008; OHSAS18001
（Occupational health and safety management system）
Obtained in 2009; ISO45001
（Occupational health and safety management system）
Obtained in 2019

Small-lot manufacturing of numerous types of products, focusing on generic drugs.: The Inami Plant is our primary facility for generic drug manufacturing, and began operating as a Kyorin Group plant in 2005. The plant manufactures more than 200 products, including contracted manufacturing from outside the Group. The plant’s specialty is its flexibility that enables it to manufacture small volumes of pharmaceutical products in various forms, including solid formulations taken internally, and liquid formulations including sterilized formulations for injections, eyedrops, and nose drops. Visits from drug manufacturers contracting to the plant provide information that has enabled the facility to gain expertise in maintaining stable supplies of highquality products. Along with responding to the growth in demand for generic drugs seen in recent years, the facility is working with the Noshiro and the Shiga plants to create a stable supply structure, and striving for even higher productivity and reliability.

Shiga Plant

Established: 1977
Site area: 61,272ｍ²

Items manufactured: Prescription drugs (drug formulations and packaging: Solid dosage forms, dry syrups, ointments/creams. Packaging: Vials/ampules, nasal sprays) and OTC drugs (solid dosage forms)
Certifications obtained: ISO14001
（Environmental management system）
Obtained in 2019; ISO45001
（Occupational health and safety management system）
Obtained in 2019

Focusing on contracted manufacturing incorporating global GMP.: For many years the Shiga Plant was a manufacturing base for a non-Japanese pharmaceutical manufacturer, and in 2012 it began operating as part of the Kyorin Group. In addition to manufacturing the Group’s main products, the plant is unique for its high portion of manufacturing contracted from outside the Group, including the manufacturing of pharmaceutical products to be sold in Japan by overseas manufacturers. The plant’s manufacturing is able to keep pace with the needs of the times, having implemented global GMP since its establishment with manufacturing equipment oriented to prevent things like cross contamination, and the ongoing introduction of the latest equipment. Using its abundant experience and expertise gained from contracted manufacturing from overseas global companies, the facility is working aggressively to increase its contracted manufacturing from outside the Group.