Drug Enterprise - Import & Sales of APIs and intermediates

Import & Sales of Active Pharmaceutical ingredients (APIs) to Japanese generic companies

The generic market is showing a continuous growth under the political scheme on cutting back the budget for health care. Under the Japanese Pharmaceutical Law, we are striving to ensure the quality of APIs and to lay more strict platform for stable supply, as is demanded by Japanese pharmaceutical makers.

In order to answer such demands, we carefully select overseas API manufacturers with software and hardware that comply with Japanese regulations, as well as good corporate compliance practice (intellectual properties including copy rights, trademark rights and patents).

We also register DMFs as an in-country caretaker and carry out audits to domestic and foreign manufacturers on regular basis.

To support the foreign makers, we work with our QA and QC to lay tough quality control and instruct them technical matters.

We are successfully growing the supply of originators’ APIs and originators’ drug intermediates. In terms of generic drugs, we import APIs and intermediates to supply to leading Japanese generic makers. We also forge partnerships with domestic API makers to sell them to the generic makers. We have recently started importing highly potent formulated drugs such as anti-cancer drugs that are hard to be manufactured domestically, as we serve as bridge between companies in and outside Japan.

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