Contract manufacturer recall slams 8 drugmakers

When does outsourcing get out of whack? When contractors don't live up to their end of the deal. Eight pharma companies were forced to recall generics in the U.K. last week after regulators found "serious" deficiencies in manufacturing practices at a single contract manufacturer in India.

Among those stung by MJ Biopharm's failures: Novartis, which had to withdraw a version of the antidepressant Prozac. The Swiss drugmaker's generics arm, Sandoz, also recalled the ubiquitous diabetes remedy metformin, and baclofen, for muscle spasms. "These were not major products, and we had already discontinued marketing them," Sandoz spokesman Chris Lewis told the Wall Street Journal, adding that Sandoz doesn't get any other products from MJ Biopharm.

Other companies that withdrew drugs include Wockhardt U.K., Jubilant Pharmaceuticals, Milpharm, and more. Jubilant Organosys, the Indian parent to the Belgian firm affected by the recall, said it has already taken that manufacturing back in-house, to its own regulator-approved plant in India. (Jubilant recalled amlodipine, the copycat form of calcium channel blocker Norvasc.)

One of London's evening papers theorized that the recall might "damage the reputation of non-branded medicines." But the more immediate threat might be to pharma outsourcing. Drugmakers have been shifting more and more manufacturing to third-party companies, but safety problems--think Baxter's heparin scandal--and manufacturing issues could cause Big Pharma to rethink that strategy. At the very least, MJ Biopharm's stumble will remind companies that successful outsourcing requires vigilant supervision. It's not a hire-out-and-forget-it proposition.

- read the WSJ story [1]
- check out the Evening Standard piece [2]

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Contract manufacturing to grow 16% yearly [4]