I feel it is my duty as a concerned citizen and independent journalist to inform you that Sandoz drugs are not safe for humans to consume. They just announced this week a class II recall of alprazolam tablets because they did not meet product spec. Class II recall are serious, it means that there is a risk of bodily harm to humans who consume the drugs. This is far more serious than the gabapentin recall, this must be a case of criminal negligence by Novartis. It must be criminal negligence because that is the only way product can be made out of spec. I'm sure our friend from the Ranbaxy board is over on the Novartis board as we speak asking for blood. Asking for resignations. Telling people to report the company to the FDA criminal investigation unit. These medicines could kill people. Novartis must be held accountable. Whats that? He's not saying anything? No one is saying anything? There is no mention on the Novartis board of this recall, at all? I don't understand? Oh, I understand now. Our friend only has an axe to grind with Ranbaxy.
I dont know what is happening.If you are so concerned about Sandoz , then post it on Sandoz board .Dont atleast spoil the name of Ranbaxy here with Sandoz recall .
narmis: jst answr this qestion plz - in most recent inspection of ranbxy facilties, did the us fda issue an unusually high shocking thirty 483's to the compny??
Yes ur right .Ranbaxy was issued 23 483s at Dewas plant and 7 at bata Mandi within a span of a month .It may lead to stoppage of their work at these facilities
But don't forget these were prior approval inspections. Should not impact product already approved and marketed.
Prior Approval inspections are ok but these are the indications of major issues underneath the big giant Ranbaxy , otherwise FDA would not withdraw the already approved product Risperidone Tablets for oral solution as indicated on CDER website and also on Wall street journal .REad the story below: Generic Risperdal Approved? Never Mind Posted by Shirley S. Wang The FDA issued a rare correction today after mistakenly saying on its Web site that the agency approved the first generic tablets of antipsychotic blockbuster Risperdal from Ranbaxy Laboratories, an Indian generics company. An approval would have been big news because the medicine is one of Johnson & Johnson’s top sellers. The first generic wasn’t expected to hit the market for months. Before the FDA corrected itself, some news outlets, analysts and investors picked up on the news. But it simply wasn’t true, according to the FDA Web site and our conversation with an agency spokeswoman. The announcement was especially surprising to Ranbaxy because it doesn’t even have tentative approval to market generic Risperdal tablets. A Ranbaxy spokesperson characterized a mistake of this nature by the FDA as “extremely rare.” When generic competition does start, J&J will get hit hard. Generally, the more profitable a branded drug, the more generics makers pile in, driving a drug’s price down steeply and quickly. The pill form of Risperdal brought J&J $2.2 billion in U.S. sales last year and accounted for 6% of company global sales, according to the latest J&J annual report. The Risperdal patent expired in December but J&J received a pediatric extension, which allows it to maintain exclusivity until late June. URL: http://blogs.wsj.com/health/2008/03/...ind/trackback/
Deepa, what do you know about 483s and how did you get these numbers. Its good to see that indian people are so much concerned about USFDA's comment. even if USFDA bann ranbaxy from selling the drugs in US what difference it will make to our life. Ranbaxy has only 20% contribution in its turnover from US. But i am really surprized to know the details about Ranbaxy 483s. Do you also know about DRL 483s?
DRL got 15 483s for their sterile facility including the manipulations for their autoclave .DRL is better than ranbaxy atleast .DRL does not trouble their employees whereas Ranbaxy is known for all its politics , wrong policies and sacking of people .
DRL screwed over its entire US operation when amlo maleate went bust. People who worked their butts off for the company were dropped. Then, the company relocated its US headquarters to be closer to the CEO's house, and a lot of loyal employees were forced to find new jobs or commute 2 hours to work. All companies have political issues and disrespect employees. Its called capitalism.
I agree. Dont lie about it, the truth is sandoz risperidone does NOT work- you may as well be taking a placebo. when using sandoz products i went into a relapse phase and i know for a fact it was because sandoz gives poor quality risperidone. americans dont have a clue the indian firm ranbaxy are on top again.
Americans don't have a clue that all our jobs went over to India either. We are just dumb white / black people...
