PMDA confirms investigation of Osaka API firm Yamamoto Chemical

By Gareth Macdonald

- Last updated on GMT


Related tags Japan

Japanese regulators are investigating allegations API firm Yamamoto Chemical Industry gave inspectors false information and improperly bulked-up batches of acetaminophen and zonisamide.

Osaka-based Yamamoto Chemical was ordered to temporarily cease business activities by authorities in Wakayama prefecture on June 29 (here​ in Japanese).

According to the order the firm made a “false” report during an inspection of its plant in Wakayama City in May.

Elsewhere reports​ in the Japanese press also suggest the firm mixed ingredients made at the Wakayama City site with stocks of the same actives made in China without completing the required documentation.

A spokesperson for the Pharmaceuticals and Medical Devices Agency (PMDA) confirmed the agency is examining the Yamamoto Chemical case but declined to provide additional information when contacted by

Yamamoto Chemical did not respond to a request for comment.

Surprise inspections

In related news, Japan’s Ministry of Health, Labor and Welfare (MHLW) has urged regional authorities to carry out surprise inspections of API manufacturing sites.

The MHLW notified prefectural authorities of the need for surprise inspection on June 29 (here​ in Japanese), explaining they should prioritize manufacturers at which quality problems are likely to have the biggest impact.

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