NAGASE & CO., LTD.
Nagase Medicals Co., Ltd.
June 13, 2016

Nagase Medicals will strengthen the production capabilities for high potency injection drug～Construction of new building and introduction of freeze dry production line ～Nagase Medicals Co., Ltd. (Nagase Medicals, Head office: Osaka, factory: Hyogo), President：Mitsuru
Akasaka), a wholly owned subsidiary of NAGASE & CO., LTD. (Head office: Tokyo, President: Kenji
Asakura) will add a new building to the injection production building dedicated for high potency
pharmaceuticals(*1) (2nd Injection Building), which was completed in February 2013 to strengthen
the production capacity.
Based on the production technology of sterile product, mainly injection liquid formulation, Nagase
Medicals serves as the core of the NAGASE Group’s pharmaceuticals business.
Traditionally, Nagase Medicals has been managing contract manufacturing of high potency
injection drug, mainly oncology injection. In order to further enhance its production capabilities,
Nagase Medicals had built 2nd Injection Building dedicated for the production of vial injection liquid
formulation of high potency in February 2013. Since then, Nagase Medicals expanded in-housedevelopment and production of high potency generic injection drug and contract manufacturing ofinvestigational product and commercial product.
In order to further increase manufacturing items and reinforce in-house development items, Nagase
Medicals will build a new building next to 2nd Injection Building, which will be connected to 2ndInjection Building. With the completion of this new building, production function of injection drug forhigh potency drug will expand significantly.

Image of the new building【Brief overview of the new building】
Location

4-323, Senzo, Itami, Hyogo, 664-0898

Building Area

1,582 square meter

Building structure

Steel-framed structure, 4 floors

Main purpose

Lyophilized and liquid formulation of ethical drug andinvestigational drug including high potency drug

Main equipment

Sterile isolator at filling section, Freeze dryer (suitablefor high potency drug), Filling line suitable for single-use
systemCompletion andCompletion of the building in August, 2017

Commencement of operation

Commencement of operation at the end of 2017

Investment amountJPY 2.5 Billion【Aim of construction】
The original concept of the 2nd Injection Building; that is, preventing cross contamination andhandling multiproduct by utilizing single-use system(*2) ; advanced sterile assurance by the
introduction of sterile isolators(*3) ; and installation of advanced containment system will bemaintained. Meanwhile, due to the expansion of the new building, new function will be acquired andexisting function will be enhanced such as 1) acquisition of freeze dry function, 2)significant
expansion of the production capacities (more than 2.5 times compared with the current capacity) and3)improvement and expansion of inspection and packing function. Moreover, in this new building, wewill secure the space for new equipment as we plan to introduce small-scale production line for highpotency drugs suitable for investigational drug in the new future.

As for high potency injection business focusing on oncology drug, we will promote the business byutilizing the comprehensive strength of the NAGASE group from sourcing active pharmaceuticalingredients to producing final drug products.
*1) High potency injection product: Injection product such as oncology drug that is highly active andrequires containment*2) Single-use system: Disposable production line, where contact section with the liquid is single-use
per lot from solution preparation to the needle of filling device.
*3) Sterile isolators: Isolator system that can maintain sterile environment. This system isused when aseptic filling of drug solution is performed.

【Summary of Nagase Medicals Co., Ltd.】
Representative：

Mitsuru Akasaka

Head Office：1-1-17 Shinmachi Nishi-Ku Osaka, JapanFoundation：

July 1, 1972

Type of Business：

Manufacture and sale of pharmaceuticals, animal drugs, health foods, andcosmetics

Capital：

498 million yen

URL：

http://www.nagase-medicals.co.jp/【Contact for this information】

NAGASE & CO., LTD.
Life & Healthcare Product Department, Pharma-Medicals Division, Sales 2nd Section
Tel：+81-3-3665-3333 FAX：+81-3-3665-3940
Finance Division, Public & Investor Relations Section
Tel：+81-3-3665-3028 FAX：+81-3665-3930
URL：http://www.nagase.co.jp/