The TGA has advised CMA to inform our members of the status of a chemical substance manufacturer, which may be of relevance to our members.

The US FDA recently issued a warning letter to the Nippon Fine Chemical Company, an API and chemical substance manufacturer. The warning letter was issued due to the site’s personnel physically obstructing FDA inspectors and refusing to hand over documents for review. The FDA has also placed the site on import alert.

No medicines supplied in Australia nominate this site for API manufacture, however, the TGA is aware that some excipients may be sourced from there.

The TGA request that CMA members verify with your manufacturers whether any raw materials for their medicines are sourced from the Nippon Fine Chemical Company, and if so, undertake a risk assessment in light of the warning letter.