Haw Par

Haw Par: warning from the US Food and Drug Administration (FDA) for violating manufacturing standards at its Singapore plant (ie. deficient records, incomplete lab tests, sloppy procedures, inadequately trained staff), and for ‘misbranding’ its pain-relief patch as an external painkiller, when it qualifies as a new drug and needs approval. Haw Par has 15 working days from receipt of the warning letter sent out on 20 July, to address the FDA’s concerns or its pdts may be banned from the US...

While there could be near term concerns, impact should be mitigated by Haw Par’s relatively low US sales exposure (S$10.5m, or 14% of healthcare sales in FY09), long track record of sales in the US since before 1998, and its ability to meet stringent health authority standards in other developed countries like Singapore, Japan, Germany, UK.