Maruishi Pharmaceutical Co.,Ltd.|Business Activities

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Partnering

We highly respect and value partnership with other pharmaceutical companies, bio-tech ventures, universities and research institutions, because we believe it is essential to enrich our product pipeline

We are actively seeking various forms of collaboration opportunities, form joint-research, co-development, co-marketing, co-promotion to in-license in Japan.
For markets outside of Japan, we develop and deliver high-quality pharmaceuticals through local partners or partners that have strong presence in the area for each country.

We are dedicated to build trusting relationships with the partners and hope to make most out of the collaboration to create a positive circle that will lead to further research and development. Our focus therapeutic areas are perioperative area, infection control, acute care diseases and cancer supportive care.
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If you are interested in partnering with us, please contact us from here.

Sales and Marketing

Our main marketing activities cover the areas of anesthesia during surgery and general procedures, as well as pain relief and infection control. In addition, we are committed to supplying high quality basic drugs (Japanese Pharmacopoeia drugs) stably and sustainably.

In our sales and marketing activities, we aim to promptly and accurately provide the latest evidence-based information to healthcare professionals, whilst simultaneously collect information from healthcare professionals in order to contribute to the improvement of shared information at every opportunity.

Pharmaceuticals only have value when both "high-quality products" and "information on safety, efficacy, and proper use" standards are met. To ensure that patients and their families receive safe and appropriate healthcare services, we strive to build trustful relationships with healthcare professionals with a high level of awareness of compliance.

Research and Development

We have been engaged in R&D activities mainly targeting the perioperative area, infection control areas, acute care diseases and cancer supportive care in order to meet neglected medical needs for healthcare professionals, patients and their families. The R&D activities include the search for R&D seeds, basic drug discovery research, formulation design, CMC related studies, non-clinical studies, clinical trials and post-marketing studies to name a few.

When searching for R&D seeds, there are various points we must take into account, such as evaluation of development candidates, screening of various pharmacological effects, elucidation of drug efficacy mechanisms, evaluation of efficacy using microorganisms, and research on the synthesis of metabolites and degradation products.

This in turn leads to development of candidate compounds created through internal or external research, proceeding to formulation design aimed at maximizing product value.

We then conduct studies necessary for the application of pharmaceuticals, which are in compliance with the latest regulations in order to deliver them to those who need them.

In addition, candidates with confirmed efficacy and safety in non-clinical studies proceed to human clinical trials in accordance with GCP (Good Clinical Practice) and get approved if the trials are successfully completed.
We also support research aimed at creating new evidence based on medical and scientific information of our products and their surrounding areas, leading to life-cycle management.

Quality, Safety and Regulatory Affairs

In order to ensure the reliability of pharmaceuticals, the Quality Assurance Department, Pharmacovigilance and Post Marketing Surveillance Department, Auditing and Quality Assurance Department (specialists in laws and regulations), and the Pharmaceutical Regulatory Affairs Department, which supports operations under the Pharmaceutical Affairs Law, are working together to promote the pharmaceutical management system.

Quality management and safety management are at the core of Maruishi’s business and are consistently conducted by quality assurance managers and safety control managers in accordance with the GQP (Good Quality Practice), GVP (Good Vigilance Practice) and GPSP (Good Post-Marketing Study Practice) under the supervision of a general marketing supervisor.

By taking appropriate measures as needed, we strive to ensure that pharmaceuticals that meet approved requirements and are both safe and of the highest quality, can be provided to healthcare professionals and patients stably and sustainably.

Regarding application data for drugs in development, we have established a system to conduct surveys and audits to ensure that non-clinical study data is collected according to GLP (Good Laboratory Practice) and reliability standards, and for clinical studies data is collected according to GCP (Good Clinical Practice).

In order to further strengthen quality assurance, we have cross sectoral meetings which regularly involve executive management, and we have established our quality management manual in accordance with the ICHQ10 Guidelines for Pharmaceutical Quality System.

Our Quality Management System covers the entire life cycle of pharmaceuticals to ensure the highest possible level of quality.

Production

Our main factory, Imazu Plant, located in Osaka, Japan manufactures approximately 30 different products including basic drugs, disinfectants and perioperative drugs.

The factory is divided into sterile and general preparation zones. Our manufactured formulations are injectable, oral preparations, external liquid preparations and ointments.

Our main products, such as anesthetics, analgesics, sedatives, and ointments, are produced in dedicated and automated manufacturing lines to ensure stable supply with consistently high productivity.

In addition, we are pursuing the establishment of higher-quality systems in order to respond to the revised GMP (Good Manufacturing Practice) and GDP (Good Delivery Practice).

We are committed to provide the highest quality products to healthcare professionals and patients stably and sustainably.