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AZ to outsource API-making to Asia
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AstraZeneca says it's not going to make drugs from scratch anymore. The company plans to farm out production of its active ingredients. All of them. "Over the next several years we would seek to outsource all of our active ingredients," a company spokesman told The Times of London. The move will save the drugmaker money, of course. But will it raise questions about quality?
According to the Times, AZ's manufacturing plans call for much of the API production to move to Asia, mainly China, though the company mentioned India as a possible manufacturing site as well. And as you know, there have been plenty of questions raised about the quality of Chinese-made drug ingredients; just consider the big heparin debacle of winter 2008.
Apparently the company realizes that the move could be greeted with skepticism. A spokesman emphasized to in-Pharma Technologist that AZ's own inspectors will check out suppliers' production facilities regularly to make sure quality is maintained. And the changes won't happen overnight, either. Production will shift to Asia over the next several years, giving the drugmaker time to gear up its quality control.
A couple of years ago, an AstraZeneca EVP raised eyebrows by pledging to outsource all the company's manufacturing, starting with active ingredients. But the company quickly backpedaled on that pledge, saying the executive was actually misquoted; the plan was to begin looking for contractors that could take over some API work. Well, that's obviously happening now. We'll have to wait to see how it plays out.
- read the Times story
- get more from Pharmalot
- check out the in-Pharma piece
Related Articles:
API manufacturing gets makeovers
AstraZeneca: Just a bit of outsourcing
AstraZeneca to outsource manufacturing
Comments
By Anonymous | Posted 4:45pm | November 30, 2009
Where are the regulators? How can drug makers move production to China without prior relatory approval? How do they get away with not disclosing where their drugs are made and/or where the active ingredients come form. Are doctors and consumers informed? Why aren't they given a choice? I would never knowingly use any medication or nutrional supplement that is made in China. My experience is they are cheaper because they are inferior and unreliable.
By Anonymous | Posted 1:26pm | December 1, 2009
There are a lot of questions in this "comment." Perhaps a few answers would help dispel some of the angst. A change in the site of manufacture for an active drug ingredient requires a "prior approval" by the FDA, or other regulatory agencies (EMEA, TGA, etc.) In order to file for this the manufacturer has to produce stability batches and produce appropriate scientific data that proves the potency, efficacy and purity of the drug. They have to file this with the FDA. Additionally, the active ingredient manufacturer has to file a Drug Master File with the agencies and be auditted. Most major pharma companies have proven reliable sources in China and India.
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