Rebamipide

PDF (277KB)PDF For Immediate Release Company name: DAIICHI SANKYO COMPANY, LIMITED Representative: Joji Nakayama, Representative Director, President and CEO (Code no.: 4568, First Section, Tokyo Stock Exchange) Please address inquiries to Noriaki Ishida, Executive Officer, Vice President, Corporate Communications Department Telephone: +81-3-6225-1126 http://www.daiichisankyo.com/ Tokyo, Japan (December 10, 2015) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that its generics subsidiary, Daiichi Sankyo Espha, is launching fourteen new generic drugs with six new active ingredients on Friday, December 11, as well as two new generic drugs with one new active ingredient in March 2016. Overview 1. Product names/therapeutic categories 1) Products launched on December 11, 2015 Product name Therapeutic category Original brand name Sertraline Tablets 25mg “DSEP” Selective serotonin Re-uptake inhibitor JZOLOFT® Tablets 25mg, 50mg Sertraline Tablets 50mg “DSEP” AMVALO® Combination Tablets “DSEP” Selective AT1 receptor blocker/prolonged Ca antagonist combination EXFORGE® Combination Tablets AMALUET® Combination Tablets 1Ban “DSEP” Prolonged Ca antagonist/ HMG-CoA reductase inhibitor Caduet® Combination Tablets 1Ban, 2Ban, 3Ban, 4Ban AMALUET ® Combination Tablets 2Ban “DSEP” AMALUET ® Combination Tablets 3Ban “DSEP” AMALUET ® Combination Tablets 4Ban “DSEP” TAZOPIPE® Combination I.V. Solution 2.25 “DSEP” β-lactamse inhibitor combination Antibiotic agent ZOSYN® I.V. 2.25, 4.5 ZOSYN® I.V. Bag 4.5 TAZOPIPE® Combination I.V. Solution 4.5 “DSEP” TAZOPIPE® Combination Drip I.V. Bag 2.25 “DSEP” TAZOPIPE® Combination Drip I.V. Bag 4.5 “DSEP” Rebamipide Tablets 100mg “DSEP” Treatment for gastritis/stomach ulcer Mucosta® Tablets 100mg Tamsulosin Hydrochloride OD Tablets 0.1mg “KN” Treatment for urination disorder due to enlargement of prostate Harnal® D Tablets 0.1mg, 0.2mg Tamsulosin Hydrochloride OD Tablets 0.1mg “KN” *Joint launch with Kobayashi Kako * Regarding the TAZOPIPE formulation, in addition to initial indication (septicemia, pneumonia, pyelonephritis, cystitis), it has already received approval with one change (additional indication: febrile neutropenia (adults)) on November 25, 2015. 2) Products launched in March 2016 Product name Therapeutic category Original brand name CAMSHIA® Combination LD “SANDOZ” Prolonged angiotensin II receptor antagonist/prolonged Ca antagonist combination UNISIA® Combination Tablets LD, HD CAMSHIA® Combination HD “SANDOZ” 　　　　　　*Joint launch with Sandoz 2. Product attributes – Daiichi Sankyo Espha measures Daiichi Sankyo Espha has continued to maintain a level of quality based on the quality management standards of the Daiichi Sankyo Group. Thanks to initiatives such as the world’s first double-sided laser printing on tablets, Daiichi Sankyo Espha has contributed to innovations in formulations and labeling to make drugs easier to ingest and harder for patients to mistakenly take. These kinds of high value-added generic drugs are proposed as “premium generics.” Innovation of PTP sheets and tablets In order to prevent mistaken taking and ingestion, innovations in formulations and labeling are continuing to be developed. - Easily recognizable original symbols PTP sheets feature original symbol marks based on characteristics of formulations and diseases. - GS1 data barcode for each PTP sheet and packaging (outer box): With the aim of helping to ensure no mistaken taking of tablets, GS1 data barcodes are printed on the back of PTP sheets. Also, for the GS1 data barcodes on the packaging (outer box), in addition to fixed information (product name, dosage, etc.), varying information (manufacture lot No., efficacy period, etc.) can also be checked. - Pitch control: Clear identification by printing of product names, active ingredients, etc. in fixed positions on each tablet of the PTP sheets. - Double-sided printing (Sertraline Tablets, AMVALO Combination Tablets, AMALUET Combination Tablets, Tamsulosin Hydrochloride OD Tablets, CAMSHIA Combination Tablets): Printing of product name etc. on both sides of tablets to make them easier to distinguish. Other formulation and packaging innovations - The TAZOPIPE® Combination Drip I.V. Bag, holds a volume of solution (2.25 standard) that is not available in previous products and suitable for use on child patients who weight less, with waste reduction in mind. About Daiichi Sankyo Espha Daiichi Sankyo Espha is a company that manufactures and markets generic drugs, accommodating rising demand based on the spirit of Daiichi Sankyo Group corporate philosophy* of supplying pharmaceuticals to address diverse medical needs. Daiichi Sankyo Espha strives to provide peace of mind for users by fulfilling the most important pharmaceutical criteria of quality, information, and stable supply while delivering the economic benefits of generics. *Daiichi Sankyo Group corporate philosophy: To contribute to the enrichment of life around the world through the creation of innovative pharmaceuticals, and through the provision of pharmaceuticals addressing diverse medical needs. Daiichi Sankyo Espha Company Overview Company name: Daiichi Sankyo Espha Co., Ltd. Established: April 1, 2010 Business: Manufacture and sale of pharmaceuticals Capital: 450 million yen Representative: President Hiroto Yoshikawa Headquarters: 3-5-1, Nihonbashi, Honcho, Chuo-ku, Tokyo