Comments on: Message To Pharma: Get Out Of China, Now! http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/ News, Comment and Conversation Mon, 12 May 2008 06:33:47 +0000 http://wordpress.org/?v=2.5.1 By: The FDA and foreign drug ingredients « Tizona’s Weblog http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-219493 The FDA and foreign drug ingredients « Tizona’s Weblog Fri, 21 Mar 2008 11:04:20 +0000 http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-219493 [...] what’s the deal with FDA-approved drugs with Chinese ingredients? Some fast facts from here, here and [...] [...] what’s the deal with FDA-approved drugs with Chinese ingredients? Some fast facts from here, here and [...]

]]> By: China (again): It’s not just your pets they’re killing. « Tizona’s Weblog http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-218959 China (again): It’s not just your pets they’re killing. « Tizona’s Weblog Fri, 21 Mar 2008 03:54:23 +0000 http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-218959 [...] Pharmalot Blog (Excellent analysis of the China Pharma problem) [...] [...] Pharmalot Blog (Excellent analysis of the China Pharma problem) [...]

]]> By: On Pharma http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-195983 On Pharma Fri, 07 Mar 2008 20:14:24 +0000 http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-195983 [...] interesting Q&A on Pharmalot:  an interview with Rutgers business professor Michael Santoro (click here), who has just published a new paper on the subject of China’s drug manufacturing safety:  [...] [...] interesting Q&A on Pharmalot:  an interview with Rutgers business professor Michael Santoro (click here), who has just published a new paper on the subject of China’s drug manufacturing safety:  [...]

]]> By: Law Bites » Pharma News Briefs http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-174578 Law Bites » Pharma News Briefs Sat, 23 Feb 2008 20:42:05 +0000 http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-174578 [...] implicating the Chinese plant that manufactures the drug’s active ingredient.  Thursday, Pharmalot posted an interview with a Rutgers business professor, who thinks the pharmaceutical industry [...] [...] implicating the Chinese plant that manufactures the drug’s active ingredient.  Thursday, Pharmalot posted an interview with a Rutgers business professor, who thinks the pharmaceutical industry [...]

]]> By: Memo to Big Pharmas: Get the FUCK out of China. « Tizona’s Weblog http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-166913 Memo to Big Pharmas: Get the FUCK out of China. « Tizona’s Weblog Tue, 19 Feb 2008 04:01:00 +0000 http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-166913 [...] “China is not ready to be a chemical manufacturing hub for the United States and the rest of the world. There’s far too great a safety danger. We’re getting too many safety signals in recent months. This isn’t a catastrophe waiting to happen. This is a catastrophe that is happening.” [...] [...] “China is not ready to be a chemical manufacturing hub for the United States and the rest of the world. There’s far too great a safety danger. We’re getting too many safety signals in recent months. This isn’t a catastrophe waiting to happen. This is a catastrophe that is happening.” [...]

]]> By: Rich http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-163564 Rich Sun, 17 Feb 2008 13:31:39 +0000 http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-163564 The truth about China in the pharma industry is that most Indian companies buy Chinese starting materials and intermediate ingredients that are used to manufacture the final active ingredient in India. The final active ingredient is then used in the finished dose with which we are familiar. This finished dose is made either in India or elsewhere, but not in China. The embargo Santaro wants will not stop this Chinese to India trade. It would be much better to impose an embargo on Indian manufactured drugs that use Chinese ingredients. But then we would not have generic pharmaceuticals and we would be unable to afford medicine. The truth about China in the pharma industry is that most Indian companies buy Chinese starting materials and intermediate ingredients that are used to manufacture the final active ingredient in India. The final active ingredient is then used in the finished dose with which we are familiar. This finished dose is made either in India or elsewhere, but not in China. The embargo Santaro wants will not stop this Chinese to India trade. It would be much better to impose an embargo on Indian manufactured drugs that use Chinese ingredients. But then we would not have generic pharmaceuticals and we would be unable to afford medicine.

]]> By: Ed Silverman http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-159592 Ed Silverman Fri, 15 Feb 2008 17:30:50 +0000 http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-159592 Hi Bingo, You're correct. I was referring to the sole supplier of the active ingredient. I wrote about that in earlier post, which you can see here... http://www.pharmalot.com/2007/10/ru-486-abortion-pill-is-made-in-china-after-all/ I should have been more specific. Apologies for the confusion. I will fix the post. Thanks for writing in. Cheers ed Hi Bingo,

You’re correct. I was referring to the sole supplier of the active ingredient. I wrote about that in earlier post, which you can see here…

http://www.pharmalot.com/2007/10/ru-486-abortion-pill-is-made-in-china-after-all/

I should have been more specific. Apologies for the confusion. I will fix the post. Thanks for writing in.

Cheers
ed

]]> By: Bingo http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-159539 Bingo Fri, 15 Feb 2008 17:23:28 +0000 http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-159539 Ed, Just a point of clarification... It is my understanding that there are actually no Chinese-manufactured finished dose products approved for import and sale in the United States. In Pharmalot and elsewhere I have read statements indicating that Shanghai Pharma Group is "the sole US supplier of the RU-486 abortion pill." Are you certain they are manufacturing the finished dose? More likely they are the manufacturer of the bulk active ingredient. This may not sound like an important distinction, but it is significant because it would mean that the manufacturer of the finished dose would have ample opportunity to check the quality of the active ingredient. Of course, that doesn't mean they actually do. I believe that the problems at Shanghai Hualian were related to contamination of the finished dose rather than the bulk active ingredients. If you're worried about active ingredients, Shanghai Pharmaceutical Group subsidiaries hold numerous Drug Master Files, which are necessary for import of active ingredients for sale in the US. Presumably they have some customers here. Ed,

Just a point of clarification…

It is my understanding that there are actually no Chinese-manufactured finished dose products approved for import and sale in the United States. In Pharmalot and elsewhere I have read statements indicating that Shanghai Pharma Group is “the sole US supplier of the RU-486 abortion pill.” Are you certain they are manufacturing the finished dose? More likely they are the manufacturer of the bulk active ingredient. This may not sound like an important distinction, but it is significant because it would mean that the manufacturer of the finished dose would have ample opportunity to check the quality of the active ingredient. Of course, that doesn’t mean they actually do.

I believe that the problems at Shanghai Hualian were related to contamination of the finished dose rather than the bulk active ingredients.

If you’re worried about active ingredients, Shanghai Pharmaceutical Group subsidiaries hold numerous Drug Master Files, which are necessary for import of active ingredients for sale in the US. Presumably they have some customers here.

]]> By: Kyoto27 http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-157899 Kyoto27 Fri, 15 Feb 2008 00:43:38 +0000 http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-157899 "To get away from regulators, factories are moved further away from the centers of commerce, where local authorities aren’t paying attention or can be corrupted. That’s standard operating procedure over there…" And what do we have here at home? A few untrained Seeing Eye Dogs in charge of law enforcement at the FDA, HHS and SEC.... Good luck to all of us! “To get away from regulators, factories are moved further away from the centers of commerce, where local authorities aren’t paying attention or can be corrupted. That’s standard operating procedure over there…”

And what do we have here at home? A few untrained Seeing Eye Dogs in charge of law enforcement at the FDA, HHS and SEC….

Good luck to all of us!

]]> By: Jack2 http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-157614 Jack2 Thu, 14 Feb 2008 20:41:54 +0000 http://www.pharmalot.com/2008/02/message-to-pharma-get-out-of-china-now/#comment-157614 Clearly I haven't investigated this issue as closely as Santoro, but isn't it possible you hear a lot about problems with goods manufactured in China because China manufacturers so many goods. The basic laws of probability dictate this outcome. If the problem is as serious as he states it is, it requires government intervention. You can't expect companies to move manufacturing to more expensive areas when regulations don't require it. The profit margin on generics is small, and you will then always lose a bidding war to the company that will manufacture in China. Clearly I haven’t investigated this issue as closely as Santoro, but isn’t it possible you hear a lot about problems with goods manufactured in China because China manufacturers so many goods. The basic laws of probability dictate this outcome.

If the problem is as serious as he states it is, it requires government intervention. You can’t expect companies to move manufacturing to more expensive areas when regulations don’t require it. The profit margin on generics is small, and you will then always lose a bidding war to the company that will manufacture in China.

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