Our Ueno Techno Center, our base for manufacturing, quality control, and logistics, features a highly automated eye care manufacturing line, enabling us to produce a wide variety of products. We have achieved a high-quality, highly efficient production system through a high-quality assurance system cultivated through pharmaceutical manufacturing, flexible manufacturing lines, advanced sterility and foreign material control technologies, and centralized management of test data using a Quality Information Management System (LIMS). The center is the first Japanese pharmaceutical manufacturer to comply with FDA Part 11 *1. It has also obtained ISO13485*2 and CE marking *3 certification, and is actively promoting the supply of products overseas.
*1: FDA Part 11 = Electronic record management standards established by the U.S. Food and Drug Administration
*2: ISO13485 = International quality assurance standard specific to medical devices
*3: CE marking: A mark indicating that a product has passed European product safety tests.
At Rohto Group factories, we have obtained ISO 13485 certification (Ueno Plant, Osaka Plant, The Mentholatum Company, Ltd. (UK) UK, Mentholatum (China) Pharmaceuticals Co., Ltd., PT. Rohto Laboratories Indonesia, Rohto-Mentholatum (Vietnam) Co., Ltd., Mono Vienna, Mono Hornstein) and ISO 9001 certification (DAX Cosmetics Sp. z o.o., The Mentholatum Company, Inc. South Africa, Mentholatum (China) Pharmaceuticals Co., Ltd., Rohto-Mentholatum (Vietnam) Co., Ltd., Wen Li, Eu Yan Sang (Hong Kong) Limited), establishing a quality management system in accordance with international standards. Furthermore, at our pharmaceutical manufacturing plants, we conduct production in compliance with GMP (Good Manufacturing Practice) to deliver safe, reliable, and stable quality to our customers.