News Release

Yamanouchi Pharmaceutical Co., Ltd.

Nishine Plant of Yamanouchi Pharmaceutical Co., Ltd. Obtained Attestation of ISO9002

June 27, 2000

Nishine Plant, a drug formulation plant of Yamanouchi Pharmaceutical Co., Ltd. (President: Toichi Takenaka) obtained attestation of ISO9002* regarding Formulation and Packaging of drugs on June 19, 2000, which is the quality management system established by the International Organization for Standardization (ISO).

Nishine Plant is responsible of drugs for the formulating and packaging processes of tablets and capsules of the main products of Yamanouchi including Harnal for a treatment of the functional symptoms of benign prostatic hyperplasia, Gaster for a treatment of peptic ulcer and gastritis, and Hypoca and Perdipine which are antihypertensive agents. The plant not only supplies the products to the domestic market but also exports them to the U.S., European and Asian countries. With regard to the manufacturing of Harnal for export to the U.S. (the brand name in the U.S. is Flomax, the generic name is tamsulosin hydrochloride), the plant passed GMP inspection by FDA in April 1997.

In addition to good operation procedures as a GMP plant, Nishine Plant is carrying out the following campaign as the result of the inspection by ISO9002 for quality of operations including formulation, packaging and shipment in the whole plant.
(1) Everybody carries ISO card and posters are put up in order to make everybody know high quality operation procedures.
(2) Complete sets of documents and records that were required by ISO for each operation are prepared.
(3) Through assessment is carried out for proper implementation of each operation.
Furthermore, Nishine Plant established a manual for high quality of operation in accordance with the above-mentioned campaign. By doing so, each operation becomes transparent and can be comprehended by documents as evidence, which will further improve quality of operations.

In Yamanouchi, Yaizu Plant in Shizuoka Prefecture in Japan, a plant of Yamanouchi Ireland, a plant of Shenyang Yamanouchi in China and Meppel Plant of Yamanouchi Europe in Holland have already obtained attestation of ISO9002. Obtaining of the attestation by Nishine Plant will further strengthen the quality management system complying with the international standard.

*ISO (International Organization for Standardization ) is an international organization composed of more than 90 countries including Japan with the purpose of improving quality and environmental management. The main systems for which ISO makes review are ISO9000 series (the quality management system) and ISO14000 series (the environment management system). Nishine Plant obtained the attestation of ISO9002 from JCQA (Japan Chemical Quality Assurance Ltd.) that is authorized by JAB (The Japan Accreditation Board for Conformity Assessment), the accreditation organization in Japan, as an organization of review and registration.

[For Reference]
Outline of Nishine Plant
Location: 154-13 Daini-chiwari, Obuke, Nishine-cho, Iwate-gun,
Iwate 028-7111 JAPAN
Total area: Ca. 341,000 m2
Building area: Ca. 7,200 m2
Total floor area: Ca. 13,000 m2
Operation: Formulation and packaging of ethical drugs (tablets, capsules, etc.)