not specifically but it will be soon.

http://www.ft.com/cms/s/0/c202cdf4-8519-11dd-b148-0000779fd18c.html

FDA imposes Ranbaxy import ban

By James Lamont in New Delhi and Andrew Jack in London
Published: September 18 2008 03:00 | Last updated: September 18 2008 03:00

<script type="text/javascript" language="javascript"> function floatContent(){var paraNum = "3" paraNum = paraNum - 1;var tb = document.getElementById('floating-con');var nl = document.getElementById('floating-target');if(tb.getElementsByTagName("div").length> 0){if (nl.getElementsByTagName("p").length>= paraNum){nl.insertBefore(tb,nl.getElementsByTagNam e("p")[paraNum]);}else {if (nl.getElementsByTagName("p").length == 3){nl.insertBefore(tb,nl.getElementsByTagName("p")[2]);}else {nl.insertBefore(tb,nl.getElementsByTagName("p")[0]);}}}}</script>A decision by US regulators to ban imports of more than 30 medicines produced by Ranbaxy, India's largest drugmaker, because of concerns over their manufacture triggered a decline of as much as 10 per cent in
its share price yesterday.
The ruling - the second high-profile US action against the company this year - cast a fresh shadow over the planned acquisition of the company by Daiichi Sankyo of Japan, which stressed last night that the deal would still go ahead.
It also threatened to sharply dent Ranbaxy's international growth, with analysts estimating that the ruling affected drugs accounting for 10-15 per cent of its US sales, which last year were $390m.
The US Food and Drug Administration issued an "import alert", instructing border officials to return or destroy drugs made in the two Ranbaxy plants of Dewas and Paonta Sahib, including simvastatin, the top-selling generic cholesterol-lowering drug.
It identified violations to "good manufacturing practice" which meant it could not be sure that processing took place in sterile conditions or that there was protection against cross-contamination of pharmaceuticals. It stressed it had not found evidence that Ranbaxy had shipped defective products.
The FDA said it would maintain the ban on imports and refuse regulatory app-rovals of products from the two sites until Ranbaxy had addressed its concerns.
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said: "With this action we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality."
A spokesman for Ranbaxy said yesterday the company was "disappointed" with the decision, and added it would work with the US authorities to overcome the difficulties.
"We've been selling our products in the US for over a decade. Even after this development, the FDA is telling customers to continue with Ranbaxy medicines."
The troubles come only two months after the US Justice Department stepped up legal action against Ranbaxy, alleging adulteration of some of its products - claims that the company has called "baseless".
Agencies yesterday quoted a spokesman for Daiichi Sankyo stressing it would go ahead with its $4.6bn purchase of a controlling stake announced in June, and reinforced with an offer to buy a further 20 per cent. It is the largest foreign take-over of an Indian company.
The US faces heightened public concern over drug quality following the discovery this year of life-threatening substandard Heparin, a blood thinner, in which contamination in raw materials supplied from China was found.

FDA list of medications effected (http://www.fda.gov/cder/drug/infopage/ranbaxy/ranbaxy_list.htm)


US FDA bans Ranbaxy drugs for poor quality (http://www.financialexpress.com/news/US-FDA-bans-Ranbaxy-drugs-for-poor-quality/362491/)

The violations concerned the manufacturing process and not the drugs themselves, the agency added, urging patients not to stop taking any medications and to talk to their doctors.

A sampling of products made at the two plants showed no concerns, they added. {End Quote}

I am glad to see that we are rejecting more generic medicines especially from other countries. We have plenty of generics that are made right here in the U.S. that suck.

So instead of just banning all the drugs, they are having their feet held to fire about following proper manufacturing guidelines. That's pretty nice of them.

The violations concerned the manufacturing process and not the drugs themselves, the agency added, urging patients not to stop taking any medications and to talk to their doctors.

bkaguy, meadd823 is quite correct here. It's the manufacturing process itself and not the drugs. This actually happens all the time for generics. There is an even stricter control over generics, (I think the batch testing frequency is much higher). The fact that we see this in the news is a good thing, in that they were caught out. It's a bad thing, in that so many people have been relying on this medication for so long. But as they said - don't stop taking them!

Australia has a more strict policy regarding imported products, and we tend to not bring in quite so many generics. But, then again we are supported more by the government, and brands are subsidized by them more. (EG: a 100x 10mg tablet box of Ritalin cost me $30) So we have less need to bring in more generics because of this.

not specifically but it will be soon. It's too bad "Andrew" isn't more open minded

This is a lame personal attack, and you should be ashamed of your words. Even more so, your gloating is unwarranted and tacky. A single manufacturer being warned does not in any demonstrate that the entire generics industry is broken or in need of a federal investigation.