Lupin recalls more Suprax on purity problems, adding to Indian pharma's quality questions

In the latest black eye for India's pharma industry, Lupin is recalling some 10,000 bottles of its Suprax antibiotic in the U.S. The pills fell short of standards for purity, the FDA said in a statement on its website.

Lupin downplayed the move. "This is a voluntary recall initiated on our own and of no business consequence," a Lupin spokesman in India told The Wall Street Journal.

In itself, the recall may not be earth-shattering, but as part of a pattern of problems with Indian-made drugs, it's more worrisome. A long series of recalls and failed FDA inspections have put the Indian pharma business under a spotlight. Most recently, the FDA slapped an import ban on a Sun Pharmaceuticals plant in Karkhadi, India. It's the second drug recall for Lupin this year--and the second to affect the Suprax brand in 12 months.

Lupin is pulling two lots of Suprax (cefixime), an antibiotic; together the two lots account for 9,210 bottles. In January, the company pulled more than 53,000 bottles of its blood pressure remedy quinapril, and last April, recalled 64,000-plus bottles of Suprax because of problems with discoloration.

The size of these recalls is small by comparison with those initiated by some other Indian drugmakers recently. Ranbaxy Laboratories pulled almost a half-million bottles of its knockoff version of the Pfizer ($PFE) cholesterol-fighter Lipitor, for instance, in one of the latest incidents at that company.

But with almost half of Lupin's sales coming from the U.S. market, and its ambitions for growth in the States and around the world, quality problems are the last thing it needs. The company in February agreed to buy a Netherlands-based maker of sterile injectable drugs, Nanomi, with designs on a share of that business. A reputation for quality is key to its plans for gaining ground in the injectables market, which has been plagued by recalls and manufacturing snafus.

The laundry list of product bans, FDA warning letters and recalls at Ranbaxy and its Indian rivals have prompted new scrutiny not only by regulatory agencies around the world, but by pharmacology experts who worry that Indian-made generics aren't as effective as their brand-name counterparts. Earlier this year, Daiichi Sankyo agreed to unload its troubled Ranbaxy Laboratories subsidiary to Indian competitor Sun Pharma after its recalls and FDA import bans put a major damper on its sales. But India's pharma trade group and domestic pharma companies have bristled at the quality questions, saying that the FDA is singling out their industry for unfair scrutiny.

- see the WSJ story (sub. req.)

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