Caution: Most Generic Arimidex is manufactured in INDIA
Ladies, you may be interested to learn that almost all the new generic Anastrozoles are manufactured in INDIA. My information comes from the NIH website; I've posted links after the lists
Here's the list:
The following generic Anastrozoles are made in INDIA (almost all of them).
1. Accord Healthcare Inc. imprint AHI
2. APP Pharmaceuticals, LLCDB02
3. Ascend Laboratories, Llc AN;1
4. Breckenridge Pharmaceutical, Inc. AN;1 - Made in India
5. Cadila Healthcare Limited - A7
6. Zydus Pharmaceuticals (USA) Inc. - A7
7. Dr. Reddy's Laboratories Limited RDY;1
8. Karalex Pharma, LLC 3RP;1
9. Pack Pharmaceuticals, LLCAN;1
10. Three Rivers Pharmaceuticals, LLC 3RP;1
The following do not state where they are manufactured, so I'm gonna assume...
Cypress Pharmaceutical, Inc. 0376 (Edited to add - Twinpeaks4me called and was told that they manufacture in California and dispense from Mississippi)
Mylan Pharmaceuticals Inc. M;34
Roxane Laboratories, Inc. 54;077
Sandoz Inc SZ;171 -
There are only 2 generics that are clearly NOT made in India:
Kremers Urban, LLC 71;KU -made in Ireland
TEVA Pharmaceuticals USA Inc TEVA;A10 - made in Isreal.
Here are the links. The photos aren't so easy to cut and paste so until I I can post them just click on the links and page almost all the way down until you find the photos of the label:
1. Accord Healthcare Inc AHI http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=19246
2. APP Pharmaceuticals, LLC DB02 http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=19290
3. Ascend Laboratories, Llc AN;1 http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=19638
4. Brekenridges http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=19351
5 & 6. Candila and Zydus - http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=19338
7. Dr. Reddy's Laboratories Limited RDY;1 http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=19367
8. Karalex Pharma, LLC 3RP;1 http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=19362
9. Pack Pharmaceuticals, LLCAN;1 http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=19262
10. Three Rivers Pharmaceuticals, LLC 3RP;1 http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=19389
Not manufactured in INDIA
Kremers Urban, LLC 71;KU - Made in Ireland http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=19405
TEVA Pharmaceuticals USA Inc TEVA;A10 - Made in Isreal http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=19348
..
Comments
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Why should this matter? We're supposed to prefer Irish Arimidex over Indian Arimidex? Huh?
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In the past, there have been concerns about quality control of drugs manufactured in both India and China. Here's one article from your home town, the Washington Post (June 17, 2007) by Marc Kaufman titled "FDA Scrutiny Scant in India, China as Drugs Pour into the U.S." http://www.washingtonpost.com/wp-dyn/content/article/2007/06/16/AR2007061601295.html. (I'm still researching.)
I think many of us incorrectly assumed that the generic Arimidex would be manufactured in the US. Since it's not and since there may be issues about quality and oversight, I thought it good that everyone have full information. As with many decisions related to BC, this is clearly a matter of personal choice. Of course, informed choice is generally preferable to uniformed decision making.
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MTG, this is very interesting. I never knew you could look up the country of manufacture like that. I'm not on Arimidex but am on Tamoxifen and just looked up the last Rx I got from Rite Aid. The bottle only says made by Teva but the NIH site that you linked shows me the label which tells me that they are made in Israel. I didn't have the same success with looking up the previous bottle I had. That one came from CVS and they were made by Mylan, but the NIH site doesn't show a label for that one.
Just a comment on your title -- it should really refer to the drug as anastrozole rather than the trade name Arimidex.
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Loved that article! Thanks so much for your time and hard work about this generic issue.
As I said in another thread, my Dr is fine with it being made in India. So, I will be too. I trust she knows what she is talking about.
The article did say something that peaked my interest: "Executive Director Roger Williams said Dr. Reddy's Laboratories recently became the first Indian firm to agree to pay USP to check the quality of its products."
I like that.
I went an looked at the generic Arimidex I bought 4 or 5 days ago for $17. (1 month). Yep. Manufactured in India by Dr. Reddy's. I've researched a lot about that lab in the past few hours. I feel comfortable. 0 -
I think it is not very helpful, in my opinion, for you to post a "caution" about "most" generic Arimidex being manufactured in India. I researched all the companies and found out for myself where they were being manufactured and for "personal" reasons did not want the drugs from India. That is not to say there is anything wrong with them. Just MY personal reasons. I choose TEVA because I knew it was from Israel (another "personal" preference). I would also use Sandoz. I think your intentions may have been good by trying to inform us of this information. I just do not appreciate the way you posted the information and if we have any members on here from India, it could be an embarrassment to them. Also if India is sending us drugs which are not bio-equivalent then that is a problem with "our" FDA since they are the ones who tested these companies and granted them approval to make the generic of the drug.
I received a phone call and an email recently from the FDA in reply to some concerns I had about these companies and was assured they were all thoroughly tested before being granted their approvals and they also do further testing on them during the year to make sure they keep the generics up to the bio-equivalent standards for which they were approved. I think we all have to do our homework when it comes to medications and make intelligent decisions concerning which pharmaceutical companies we are willing to purchase drugs from. Thank you for sharing your information.
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Medigal: you make a good point. The topic title does seem alarmist.
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Ladies,
I truly appreciate your comments and this open exchange.
At the risk of incurring your (additional ?) wrath, the topic title was actually meant to be somewhat alarmist since many individuals do not realize that there is a degree of controversy surrounding drugs manufactured by India. Member_of_the_Club's comment, "Why should this matter? We're supposed to prefer Irish Arimidex over Indian Arimidex? Huh?" illustrates this very point.
My topic was not however meant in any way to be prejudice or embarrassing to our fellow members from India. Just as the US has seen controversy surrounding certain problems with proper medical coverage, e.g. the timing and frequency of Mammograms and Breast MRIs, India has had controversy surrounding its fast growing pharmaceutical industry. It is not me that had singled out India and China; there is consensus, including from the press.
Lisa34lisa is 100% correct to point out that certain companies like Dr. Reddy's have agreed to pay for checks on the quality of its products.( I'll try to find out what other companies, if any, have done the same.) And of course, if you're aware of the issue and have made a knowing decision either way; I am by no means saying I'm any more correct that you are. We each make so many decisions through this journey. There are no right or wrong ones.
In the meantime here's another another article, this one from US News and World Report (October 5, 2007) , by Nancy Shute titled "Are Your Drugs Safe? Shoddy and fraudulent pharmacy products pose a growing threat" http://health.usnews.com/health-news/managing-your-healthcare/healthcare/articles/2007/10/05/are-your-drugs-safe.html
Although not strictly on point, the article states in pertinent part:
"Gone are the days when Americans could unquestioningly trust in the quality and authenticity of their pharmaceuticals. So far, no American deaths have been linked to shoddy or fraudulent medications. But a surge in hazards discovered at home and abroad has cast new doubts on the safety of prescription and over-the-counter drugs, supplements, and other medical products. Americans "should be quite concerned," says Roger Williams, CEO of US Pharmacopeia, a private organization that creates the nation's official quality standards for drugs.
Americans still have the best pharmaceutical products in the world, says Williams. But the safety net is getting frayed. Recent problems with other goods imported from China, such as the melamine that tainted pet food and killed dozens of dogs and cats, and toothpaste made with diethylene glycol, have sparked worry that the pharmaceutical industry's rapid migration to manufacturing plants in China and other Asian countries is increasing the risk of similar problems with medicines.
Explosion of imports. In the past five years, Chinese pharmaceutical imports into the United States have more than doubled, to $698 million. Already, half of the aspirin used worldwide comes from China, as do 35 percent of the painkiller acetaminophen and almost all synthetic vitamin C. India's pharmaceutical imports into this country increased 2,400 percent, to $789 million, from 1996 to 2006, making it the fastest-growing drug importer. Last year, Indian firms won Food and Drug Administration approval to import more than 100 generic drugs, including a version of the anti-HIV drug Retrovir. India and China make about 20 percent of generic and over-the-counter drugs sold in the United States and at least half of the "active pharmaceutical ingredients" for pills made within the United States. "Ten years ago, the Chinese and Indian API market was nonexistent, and now they're dominant," says Lynne Jones Batshon, executive director of the Bulk Pharmaceuticals Task Force, a group of ingredient manufacturers. Price is a key driver of that shift, Batshon says, and complying with American regulatory requirements is expensive......
The FDA sends inspectors to domestic production facilities about every two years to make sure that they're in compliance; the inspections can take months. But the agency's enforcement division doesn't have the resources to inspect more than a tiny fraction of manufacturers overseas. Between 2,000 and 3,000 overseas pharmaceutical manufacturers that sell to the United States are registered with the FDA. Some of those have not been inspected in eight to 10 years, an FDA official told a congressional committee last month. And the suppliers of ingredients to those importers never get a look-over. "The FDA doesn't have the people who can go to these countries and inspect," says William Hubbard, a former associate commissioner for policy and planning at the agency. "The enforcement side has been cut drastically."
Edited to add: Medigal wrote, "Also if India is sending us drugs which are not bio-equivalent then that is a problem with "our" FDA " - I wholeheartedly agree. In my opinion, there is a huge problem with our FDA.
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OK, I was reacting to the title, which some folks could take as a slur. I don't doubt that imported meds can raise safety issues, but I don't think we should be at all confident about what goes on here either. In a prior professional capacity I went behind the scenes in a well known pharmacy chain and found that their empty pill bottles were caked with dust from other meds and that the knife they used to cut and count pills was caked with the remnants of other prescriptions. I nolonger will fill prescriptions from this chain.
But eventually we have to take a leap of faith and take our meds. None of these articles refers to a single known incident with meds from India.
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MTG: I apologize for seeming harsh on you in my post last night. I think it was because you singled out India and I really have a concern about a lot of other companies "our" FDA is so-called protecting us from. I have sent the FDA so many emails AND phone calls concerning our drugs that I was surprised they replied. I had to laugh out loud when one rep proudly told me the FDA oversees the companies by reading the reports they have to send to the FDA and if they change any of the bio-equivalency of the medication or anything which got them their approval, they can face serious charges from FDA. WELL! Do I have STUPID written on my forehead?? If a company finds a problem do they really think they are going to list it in YELLOW or something so they can be spanked?? Maybe I am getting pill paranoid but all they have to do is change the results in their reports!! Not saying any decent company would or should do this but I don't appreciate being given information like I am two years old.
So they had another agent call me to reassure me that the FDA takes all precautions to protect our drugs yada, yada, yada etc. I am sure the FDA with the short funds it probably gets since our great country is now in the financial pits, does whatever it has the funds to do. As for us, we can either go without meds or do a holy chant or something before we swallow ANY pill! I think I will go for the chanting and hope for the best. This is why I try to research all companies before I buy their products. Chanting and researching is as much as I can do because remember, if I were completely without medical problems, I would not have to take drugs and wouldn't be posting on this board. I also appreciate others who share their research on this forum. I want to learn as much as I can. Thanks!
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I would not consider this post alarmist. I am very glad someone let me know. I have already gotten stuck with antibiotics from India that turned out to be worthless and it caused a problem with the bacterial infection getting futher. Thank you so much for warning me. I will be sure to make sure my onc specifies my prescription.
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I also became concerned and I called my mail order provider. They told me that Cypress Pharmaceutical manufactured my RX. They didn't know where it was made, but gave me phone # to call Cypress. I told them to look on the huge bottle that they fill a 90 day supply from. Ha. They said call Cypress. I called them and they switched me to customer service and they assured me that it was manufactured in California and dispensed from Madison, MS. I still have over 2 months of Arimidex to take before I switch over. 90 days generic is $106.92 from my mail order RX. I started as an April 1st FOOL and so wish that I'd wake up and 5 years were over.
In 1996, I was treated and survived large B cell lymphoma. Both my BS and ONCO DR think the bc came from the radiation treatment I had in1996. Now having finished 34 more rad treatments on 3/31/10 I'm nervous. My original rads were mantle radiation to my entire chest area. Lung re-section surgery on right, bc on left side in the very upper outer 1/4. I'm just holding out with the hope that beating it once I can do it again.
Have a great day looking into the weekend.
Leslie
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I thank you for bringing this to our attention. I, too, assumed our pharmaceuticals were manufactured in the United States. I don't buy beauty products, foods, etc., made in China. You can call me politically incorrect all you want, but I'd rather be safe than sorry.
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Okay, some more info on Mylan - found on their web site, http://www.mylan.com/our_businesses/active_pharmaceutical_ingredients.aspx. (Although I've bolded to sentences I found most interested, I've not added nor deleted anything.)
Through its subsidiary Matrix Laboratories Limited, Mylan has direct access to one of the world's largest active pharmaceutical ingredients (API) manufacturers. This relationship makes Mylan one of only two global generics companies with a comprehensive, vertically integrated supply chain.
Matrix produces API in a wide range of categories, including antibacterials, central nervous system agents, antihistamines/anti-asthmatics, cardiovasculars, antivirals, antidiabetics, antifungals, proton pump inhibitors and pain management drugs. Matrix also is one of the world's largest producers of API used to make generic antiretrovirals (ARV), which are used to treat people living with HIV/AIDS.
Based in Hyderabad, India, Matrix has several operating units, including a network of API and intermediate manufacturing facilities in India and China. Its subsidiaries include Matrix Laboratories N.V., Matrix Pharma Group (Xiamen) Limited and Astrix Laboratories LTD.
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twinpeaks4me, it looks like Cypress Pharmaceutical doesn't make the anastrozole your pharmacy is providing -- they just market it. Using the website MTG gave us, I looked up "anastrozole" and found the link for Cypress Pharmaceutical:
http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=19244#section-17.6
Way down near the bottom of that page is the image of the official product label. It says the product is "Manufactured for Cypress Pharmaceutical, Inc., Madison, MS 39110." Note that the statement says "for" and not "by".
Even farther down the page is the following, under "Marketing Information":
Labeler - Cypress Pharmaceutical, Inc. (790248942)
Registrant - Stason Pharmaceuticals, Inc. (807437553)
Establishment Name Address ID/FEI Operations
Stason Pharmaceuticals, Inc. 807437553 manufactureSo, apparently, Cypress is the company marketing the anastrozole you'll be getting, but it's being manufactured by a different company - Stason Pharmaceuticals, Inc. The place where the form says "Address" is blank. I googled "Stason Pharmaceuticals" and found this:
"Headquartered in Southern California, the Stason group employs approximately 120 people worldwide. We have R&D and manufacturing facilities in California, USA, and Taiwan. Additional R&D facilities are located in Massachusetts, USA, and China. Our licensing offices are located in California, USA and Tokyo, Japan."
I'm not suggesting there is anything suspicious about that. It sounds like they're using their California facility for your anastrozole. I guess that would be a good thing, yes? The economy is global; we all know that. I just think it's amazing that it's so difficult for the average consumer to figure out where her prescription drugs are being manufactured these days.
otter
[I just saw MTG's post, which slipped in while I was composing this. The plot thickens, eh?]
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Otter-thanks for your investigation. To say the least I'm more confused than ever. Like you mentioned why do they have to be so secretive. If feel like we're taking drugs on the sly. Believe me, if I was to do that it wouldn't be these ****** little white pills. The more I read the more I dispise these pills. Have a great weekend ladies.
Leslie
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There has been some discussion on our Australian forum about this....not about where the drugs are made but perhaps some of the fillers in the generic brands causing debilitating side effects. One lady was tolerating a generic brand and when she tried another (she moved and her local pharmacy didn't stock the one she had been on) had terrible SEs.
Then (from memory) went on the original ....not generic and her symptons disappeared.
It was written up in a BC mag here as well. Quite a few seemed to have SE from some fillers and changed to a different brand.
Just thought I would mention it.Maybe if anyone was having problems with a generic to ask your onc about it as I had been under the impression that all fillers would be the same...apparently not.
jezza
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Jeeza, I can understand a concern about taking generics one knows nothing about. That is why I try to stick with companies my Mail Order Pharmacy uses because I have tried the brands and have had no problem with their generics. I, personally, would not want to use even a brand named drug if it was made in a country I feel unsure about. It is very important to find out as much as we can about the drugs we must take. If I have any concerns about my meds I call the pharmacy immediately.
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Jezza - Thanks for the heads up. I know the same thing happened to some ladies on the Tamoxifen thread, they had adverse reactions to certain fillers. Would you happen to know which manufacturers' pills were causing the problems ? If possible could you post the article or a link to it ?
The NIH does require the manufactures to post a list of their fillers or Inactive Ingredients, just below the Active Ingredients. Not that I recognize most of them For example for Cadila, http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=19338 ,
Inactive Ingredients
Hypromellose
Lactose
Magnesium Stearate
Polyethylene Glycol
Sodium Starh Glycolate Type A Potato
Povidone
Titanium Dioxide
Unfortunately, unless someone has a clear cut allergy like to milk or lactose, there doesn't seem to be any rhyme or reason as to why some fillers cause SE's in some women. I hate that there's yet another BC thing that's a crap shoot
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In the UK women on Tamoxifin -have tons of problems with the generics they didn't have with the original manufacturer AstraZeneca. AZ has stopped making the product because generics have become so popular. It doesn't make sense.
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Hello All,
When I was on Arimidex, my measured serum estradiol was about 22 pg/ml, much higher than I expected and wished for this AI. At the time, I researched how accurate serum assays are, whether pre-test factors (like immediate freezing of the serum, as is suggested) could influence the read value and I pretty much chalked it up to that plus not knowing if the lab used on my blood actually had a low enough threshold of the immunoassay to detect it's lower limits (around 3pg/ml) rather than higher threshold for group runs.
In March, 2010 I read the article I link below suggesting that about 83% of anastrazole takers have deep suppression of their estradiol, and the balance percentage are more variable. The researchers are well known. Now I believe I probably fell into that 17% range.
I mention this during this discussion of bioefficacy of generics. One way to perhaps monitor your switch from brand to generic would be to get a serum estradiol. If it's way above the suggested upper limit, you might talk with your oncologist. A caveat is that no researcher, clinician knows "how low to go" or is good enough, so a value of 23 pg/ml (which I had) may be low enough, or might warrant discussion of switching to another AI to get the estradiol down lower (always hear about 3 to 7 pg/ml) is felt expected on an AI.
Regarding generics, my personal view is we should be cautious. Recalls do occur: my daughter was taking a generic made by Teva Pharmaceuticals which was recalled. Just keep your eyes and ears open.
Here is the link to the article by Dr. Ingle and Budzar et all:
Cancer Res. 2010 Apr 15;70(8):3278-86. Epub 2010 Mar 30.
Variation in anastrozole metabolism and pharmacodynamics in women with early breast cancer.
Ingle JN, Buzdar AU, Schaid DJ, Goetz MP, Batzler A, Robson ME, Northfelt DW, Olson JE, Perez EA, Desta Z, Weintraub RA, Williard CV, Flockhart DA, Weinshilboum RM.
http://www.ncbi.nlm.nih.gov/pubmed/20354183
I'm enjoying the summer, and doing ok. I do still check in from time to time at bc.org forums and wish you all well.
Regards,
Tender
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Tender,
Thank you ! As someone who was switched from Tamoxifen because I was a "Poor Metabolizer", I find the study fascinating and more than a bit disturbing. I was angry before that women aren't told that there's a commercially available test to see if Tamoxifen is being metabolized but felt comfortable that Arimidex was a so-called active drug and there couldn't be the same issue. Ha ! Now I know better and will look into getting a test. Just goes to show, we've got to be our own advocates and remain vigilant as well.
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Yeah, you're right. It is disturbing - VERY disturbing. Especially considering that the writing has been on the wall about this for years and so many women are depending on the efficiency of their AI - with some even questioning it yet still not getting any answers and having to fight for a simple estrogen test. It makes perfect sense that individuals are going to have different levels of response to the drug - just as they do with ANY drug. This is the very early rumblings about individual AI response going on now just as it was when there were initially concerns about about tamoxifen - and geez, look how long it took them to finally start testing for Tamoxifen metabolism. Seems to me that when they make standard of care decisions to forgo chemo in favor of only using an AI as adjuvant treatment, they should at least FIRST make sure those being advised to depend on the drug can really expect it to do for them what it's suppose to do. UGH!
http://breast-cancer-research.com/content/10/S4/S17
"...The variability in clinical tolerance to AIs raises the possibility that genetic variability in patients plays a role. Research into pharmacogenetic differences with the AIs is at an earlier stage than with tamoxifen. However, Ma and colleagues [27] sequenced the aromatase gene in 60 patients from each of four ethnic groups (Caucasian-Americans, African-Americans, Han Chinese-Americans and Mexican-Americans) and identified 88 polymorphisms resulting in 44 haplotypes.
Functional genomic studies were performed with four non-synonymous coding single nucleotide polymorphisms that were identified and a significant correlation between level of activity and immunoreactive protein was found. Three of the four coding single nucleotide polymorphisms had levels of immunoreactive protein that was significantly lower than wild-type aromatase enzyme. It is possible that patients with decreased aromatase activity would have decreased potential to benefit from the use of an AI. The findings of substantial genetic variability in the aromatase gene within ethnic groups and substantial variation between the four ethnic groups provide a strong impetus to explore pharmacogenetics of AIs...."
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A good question would be if they did the metabolic test using the Arimidex or the generic. I've personally had trouble using some generic meds.
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Good to hear from you, Tender.
My reading of this is that Arimidex lowers estrogen, but for some women it lowers it less than in others. So that isn't a failure of the drug, but perhaps there would be more success with another AI.
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or maybe, as many women here on the board have been saying/asking - does one size (dose) fit all?
Now they are finding that those whose weight is in excess of 28 BMI are not as protected as those below the threshold.
Women here have been saying this for a long time now. It is difficult to not question the researchers approach.
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Hi ladies:
Just chiming in here....I was warned by my drs. about any product made in either India, Turkey or China. I get my arimidex from Canada and it costs the same there as the generic does here.
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I think I posted this somewhere else, but I'm not sure.
Some meds "made in the USA" are not really *made* in the USA. The active ingredient is made in _______, while the fillers are made in _____ and ______. They are then shipped here, combined, and marketed as "made in the USA".
Just sayin'.
Mine are made by Dr Reddy's in India. They recently became the first Indian firm to agree to pay USP to check the quality of its products. I take that as a good sign. But, we all have to do what we are comfortable doing.0 -
Molly52, I just wanted to add that when it comes to medical problems and medications, I have found out that "weight" can be very important. Many years ago when I had to have my spinal fusion my surgeon told me he felt I would not have a problem because of my petite size and weight. It has been over 30 years and it has never given me a problem and I just breezed through the surgery and amazed him how quick I healed. Many other doctors have mentioned that my weight has been a big help with my medical problems. I truly believe I may have been so fortunate with Arimidex because although I have added 3-4 more pounds in 30 years, I still have managed to not get overweight. For the same reason, I can't take the same dosage of medications bigger people can due to my size. It all is relative, in my experience, to one's size. I cannot do any exercise due to my medical problems so I have to keep my weight down by not overdoing on fattening foods. Ugh!!! I just love my cherry cheesecake, tho!
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Just in case anyone here doesn't read the other Arimidex threads: For anyone with BCBS - as of Oct 1, there is a Zero co-pay for BRAND Arimidex (zero for the generic as well) provided your Doctor writes "Dispense as Written" on the prescription. I just learned about this yesterday, after many calls with insurance company and pharmacy. (The insurance co sent me a letter but my renewal price wasn't reflecting any change.)I've been paying almost $1,000 for a 3 month supply so I was really, really excited to learn of the change. For those with other insurance, it may make sense to call them and see if Brand A will be covered if your Doc expressly asks for it
EDITED ON OCT 7 TO ADD: My insurance is Carefirst BCBS. I re-read my letter, covering 57 oral chemotharapy drugs. and it applies to Carefirst BlueCross/ Blueshield and Carefirst Blue Choice. I'm sorry if I've misled other BCBS users; I hadn't realized that coverage differs so greatly.
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