About Us A top Japan-based generic manufacturer.

Quality Assurance Structure

Nichi-Iko carries out various tests for all drugs. We are sure that checking manufacturing processes is crucial to ensure safe and high quality drugs as well as steady supply.

Ensuring Quality

We manufacture generic drugs under the same GMP (Good Manufacturing Practices) standards imposed by Ministry of Health, Labor and Welfare regulations as originator drug manufacturers do. In accordance with this, Nichi-Iko's Quality Control Division, which is independent from the Manufacturing Division, performs various tests on raw materials and ingredients during final production stages. We conduct very strict inspections on our drug quality.

Scientific validation is used as a multi-faceted means of verifying that our manufacturing equipment, procedures and control methods are as they should be.

Our Quality Assurance Division takes the lead constantly to ensure manufacturing and quality controls are carried out appropriately in line with GQP (Good Quality Practice) regulations issued by the Ministry of Health, Labor and Welfare.

This duplicated check system of Quality Control Division and Quality Assurance Division provides superior quality products.

Ensuring Safety

Drug effectiveness comes with side effect risk. To minimize side effect risk and allow drugs to be administrated appropriately, providing information on drug safety and efficacy is essential.

Our Safety Management Department collects such post-marketing safety information. They evaluate and analyze safety information. If any changes are reported, we revise the package insert before putting it in a drug box and inform our Medical Representatives as well as external pharmacists immediately. In order to share information, we make good use of the internet, fax direct-mail as a communication tool or visit doctors and pharmacists to explain face to face.

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