I would like to get answers to following questions:\n1. As there are no formal regulations for the manufacture and control of APIs, what does the industry follow? Do they follow 21 CFR 210, 211, 600 or a guideline (S)? How did these requirements evolve? \n2.How the API industry is addressing compliance to CGMPs in the manufacture and control of chemical and biologic APIs. \n3. Are the requirements for the manufacture and control of chemical and biologic APIs the same or different? \n4. About 70% of the APIs used in the United States to support the generic drug industry are imported. Identify 3 countries that export to the US and list some of the regulatory findings (warning letters) issued in the last 18 months to a few of the API manufacturers in these 3 countries.
137854
wow... i work in a chemical company as an operator and i don't even know the answer to those without having to consult someone from our QA dept.  as far as question number 2 i can't get specific but i can say that the fda does a damn good job of keeping cgmp qualified suppliers up to task as far as testing and good housekeeping. about number 4 china and india are becoming the premier place to import bulk generics, but you should know that their governments do not regulate like the US does and while standards are still the same here testing is not as stringent and coa's are accepted. sorry that's all i know!
346392
Most doctors are 'romanced' by pharmaceutical reps every weeks. These reps offer 'incentives' to doctors who write their product a lot. My brother in law in a rep and he has taken docs to games, dinners, bought them medical equipment for their offices, etc... I have even heard of docs getting trips and other gifts. Brand drugs need to be SOLD, and as a selling profession, there has to be incentive. The active ingredients in all generics MUST, by law, be the same as their brand equivalent and vise verse. Only the 'fillers' can be altered in generics, such as coating of pill, colorant, inactive medium, etc...\n\nSome doctors may actually prefer some brand Rx over their generic equivalents, but it is not standard. The only time a doctor really needs - in my opinion - to prescribe a brand when a generic is available is if the Pt is allergic to the inactive ingredients in the generic. This is not common. But and example would be, say, someone who is allergic to wheat could not take a med with a wheat based suspension.\n\nHope this helps. There is much debate over Generic vs. Brand in the us today. Pharmaceutical companies make a lot of money and fund a lot of drug research all over the world. This is the only other argument I can think of to support selling brand Rx.
506937
Why would you like to know something about something so hopelessly quack?  Homeopathic doctors are not real doctors, so there is no true regulation over their exams and the marks required.  The training among them varies grossly.  There is no set standard, and the board is horrendous.  The practioners are doctors who for various reasons have turned to homeopathy, passing the written exam and then an oral exam.  Plenty of them have revoked or lapsed liscences as real doctors, M.D.s.  Many MDs and the Natonal Council Against Health Fraud believes homeopathy should be regulated under the same standards as conventional medicine.  Homeopathy would not stand up if forced to exist under the same scrutiny that other medicines do under the FDA.\n\n"The 1995 retail sales of homeopathic medicines in the United States were estimated at $201 million and growing at a rate of 20 percent a year, according to the American Homeopathic Pharmaceutical Association. The number of homeopathic practitioners in the United States has increased from fewer than 200 in the 1970s to approximately 3,000 in 1996. [Note by Dr. Barrett: I doubt that this figure is accurate. The number of medical and osteopathic physicians practicing homeopathy is unknown but is probably only a few hundred. A 1998 survey of chiropractors found that 53% of those who responded said that they prescribed homeopathic products to patients. If that figure is representative, about 20,000 were doing this.]\n\nWhen looking for a homeopathic practitioner, it's important to find someone who is licensed, according to the National Center for Homeopathy. Each state has its own licensing requirements. "Whether that person is a medical doctor or a physician's assistant or a naturopathic physician, I feel that anyone who's treating people who are sick needs to have medical training," says Jacobs. [Note by Dr. Barrett: Since homeopathic products don't work, going to a homeopathic practitioner makes very little sense.]"
75889
Well you could do check the below web sites and with respect to USA you must have clearances from the FDA.
551980
These may be of help into your enquiry:\n(From the FDA)\nhttp://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4050B1_02_Fexofenadine-Label-peds.pdf#search='Fexofenadine%20hydrochloride'\n\nhttp://www.rxlist.com/cgi/generic/fexofen.htm\n\nhttp://en.wikipedia.org/wiki/Fexofenadine\n\nFrom what I can understand Albany Molecular Research, Inc (AMRI) holds the patents on the manufacturing process for fexofenadine hydrochloride.\n \nThey were challenged by Barr Pharmaceuticals Ltd however.
229867
Yes, I do believe there is something to the MMR link with autism. My son has autism,and I refuse immunizations, he has never received them, so I don't believe it is the sole cause of it. Some of the things you heard here are wrong. The flu shot still has thimerasol in it. While immunizations are no longer MANUFACTURED using thimerasol, it does still exist. Not only did we send thimerasol-tainted immunizations to other countries to spread autism there, we do still have it here. If you don't check with your dr., or request thimerasol-free immunizations, you still run the risk of dumping mercury into your child. The idea that all these studies 'prove' that there's no link? First, these are people who stand to lose a great deal of money by admitting a link to autism, both because of the law suits from families who have been injured by the shots, and to the people like me who will then refuse the shots simply because once you're lied to your not as likely to go back and trust again. Second, the reports that are saying there is a link, are coming from people who are in a position to conduct these kinds of tests because they were affected by autism, and want answers. I trust them more than I do a profession who used to tell patients with asthma and bronchitis to SMOKE. Now, we know better. How do we know in 30 years, after study upon study, they finally admit to the truth. How many kids were needlessly exposed in that amount of time? Also, here's one most people don't know: There was a report written by the CDC in which they admitted that the amount of mercury being put into the shots were many times about what is considered safe. That report was then suppressed, because of the panic it would cause, and because it would show people how untrustworthy they are. People need to do the research before blindly trust a system that has continuously lied to us, and change their minds from one year to the next as to what is safe or not. Oh, and the theory that the reason why there's more cases today is because of better diagnosis? Don't believe that,either. All the cases that they are looking at to say that there is a link are kids. If the 'better dx was the case, then we would have so many adults coming forward, getting tested, and finding out they have autism. Sorry, don't fall for any of that.\n   Do we know what causes it? Not really. At the same time, we can't rule anything out, either. My belief is that they are born with a TENDENCY to develop autism when exposed to certain environmental factors, like mercury exposure. In my child's case, it was brought out when we moved.
53361
Pregnant mare urine.  There is still not a generic on the market for it because no one can synthesize it in the lab and get the same results.  They aren't even sure what all is in it to copy it.
63203
I don't think that is so high the rate (80%).The last survey that I found, was refering a smaller amount.\nThere is always the question, what we define as natural medicine ; if a medicine is natural or not after chemical processing.\nIf I understand well, you want to know the procedure of making medicines from plants. \nWell, there are various ways : \nThe most simple and easy way is to get the essential oil.\nIf you want to experiment which is the part of the plant that contains the active substance, isolate this substance and administer to patients in various dosage forms,in order to formulate a new medicine,then things are more complicated.\n\nIf you mean where to find the natural treatments,that is issues of alternative medicine, well just enter the site \nof a University, ie. Yale University or Alabama University and you can find trustworthy information.\n\nIf you want to give us here,more information in the same message, click on: Add details, that you will find on the top right of the page. It will be published in the same message that you have written and we can answer to you.\n\nKaterina
645085
I listed a couple links in respect to Federal laws & regulations as well as NC specific links.\n\nHope that helps! I wish you much success & happiness in all your ventures!
185043
This involves years and years of development and testing, and unfortunately it can't be stated in just a few paragraphs in a forum like this. I suggest doing some research online for "FDA Approval Process" and "Guidelines," as the paperwork available for this is somewhere in the thousands of pages.
273716
You're really going to have to do your own research on this one. \n\nYou've picked a very broad topic and it will be easier for you to understand if you can turn up some basic research materials on bioreactors/fermenters with diagrams.\n\n"with diagrams" is the key there. These things are easier to understand if you visualize them.
3966
Look here for the federal regulations http://www.cfsan.fda.gov/~dms/cos-cfr.html
228553
Enjoy\n\nhttp://en.wikipedia.org/wiki/Fair_Packaging_and_Labeling_Act
2455
try checking out drugbuyers.com or overseaspharmacy.com to get more info...\n\nhope this helps
247266
log on to\n\nhttp://technology.infomine.com/biometmine/biopapers/biomet_advance.pdf\n\n:)
329674
Recent news coverage examined a case where a pharmacy technician inadvertently mixed a dialysis preparation with potassium chloride instead of sodium chloride.  Both the KCl and the NaCl were made by the same manufacturer and were sold in boxes that were extremely alike.  In this case, 2 patients died before before the error was noticed.  \n\nOther common errors:\nDosage miscalculation: misreading the symbol "u" for units, or misinterpretation of a decimal point resulting in a 10 fold dosage increase. \nDispensing wrong medication due to look-alike names: For example, Accutane/Accupril, Celebrex/Celexa/Celebryx, Losec/Lasix, Narcan/Norcuron, Zantac/Zyrtec, Lamictal/Lamisil, Taxol/Taxotere, Seroquel/Serozone, hydroxyzine/hydroxyquine, Cephlex/Keflex, etc, etc....\n\nThat said, all mistakes are preventable when the appropriate measures.  A prescription should always be double checked, from start to finish, by the pharmacist, or another technician (in certain areas, where the tech-check-tech program has been implemented).  In essence, with all this checking, a prescription is essentially done twice.  Also, keeping look-alike products stored in separate areas helps considerably.
223780
The original drug is well described in a patent. The patent rights eventually expire. So, the structure is available to anyone who wants to look it up, but the actual manufacturing process is secret (unless, in the unusual case, that too is patented). So, you hire good chemists and get them to tell you how to make it once the patent expires. Sometimes, you hire a chemist who actually worked on that drug.\n\nSince brand name manufacturers know how this works, they often just knuckle under and sell the drug to generic pill manufactures who then put it in a tablet or capsule. Chances are that any asprin you buy in the US was made by Bayer, even if it has another brand on it. Since they are making it anyhow, they have all the equipment in place to sell the drug on the cheap to generic suppliers.\n\nAll this relates to the active ingredients in drugs. This doesn't necessarily mean that the tablet or capsule is exactly the same. Although, it must demonstrate the same bioavailability in testing to get on the market in the US.