Circumstantial evidence suggests that the U.S. practice of importing active drug ingredients from Asia may be running out of steam. Last year's tainted heparin fiasco may be one reason, and an April FDA warning letter to Shanghai Pharmaceutical shows just how lax operations can be half a world away.
But the list of reasons to look for others sources is growing. Rising costs and logistical issues are among them. In addition, the cost and effort involved in monitoring quality at far-flung operations is another driver of sourcing closer to home, or at home, according to a Purchasing magazine report. The promised financial benefit of Asian sourcing turns out to be "not that realistic," the report says.
Cost efficiencies remain a key concern to drug makers, of course, but API quality and a supplier's ability to deliver finished products reliably are asserting their importance.
As we've reported, contract manufacturers in North America and Europe have been ramping up their API making capacity, including that for potent compounds. Sigma Aldrich's SAFC, Cambridge Major Laboratories and Takeda are examples from earlier this year.
- here's the article