Rapamycin / Sirolimus from India, Lab Test Report on Quality / Purity

FWIW: I asked a physician colleague from India about this topic. He commented that he’d trust drugs from large well known pharmaceutical companies in India.

It should be mentioned that there is a large well known culture in India of “baksheesh” ie bribery. So if you are not buying pharmaceuticals from a well respected major Indian pharmaceutical company…

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My issue with the sirolimus generics is this: Pfizer’s brand name Rapamune was the first drug to every gain FDA approval to utilize nanoparticle technology. Rapamycin/sirolimus is poorly absorbed…the nanoparticle technology decreases particle size and increases absorption. A representative from Dr. Reedy (large generic drug company in India) told me they do not use nanoparticle to produce their generic brand of sirolimus. I think it is an egregious error for the FDA to approve generic brands that don’t use the same technology…and thus, must have significantly poorer rates of absorption than the brand name drug. The way around this…I THINK PFIZER SHOULD DROP THE PRICE OF RAPAMUNE TO COMPARE WITH GENERICS…THEN THEY WOULD SELL A TON OF RAPAMUNE…!

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"Nanomedicine approaches for sirolimus delivery: a review of pharmaceutical properties and preclinical studies"

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Damn…I found this article VERY interesting. I had no idea so many different types of nanoparticle technologies had been developed. However, if I interpret the article correctly, these nanoparticle formulations are not yet being utilized in generic sirolimus drugs from various generic drug companies…

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@RapAdmin curious, which Indian brand did you choose to use? Also, are you concerned with non- nanoparticlization, as mentioned in the comments?
Thanks

So - based on the results of the small lab test on a few batches of Indian generics - I’ve been buying Zydus and Biocon. Again - small sample size, so my confidence level in these providers is moderately high, but not extremely high. But, given that the Indian generics are $1/mg or so, vs. the typical price of $4 to $6/mg retail/street price of Pfizer name brand Rapamune, for me I feel the best choice are the Indian generics for price/performance.

The nanocrystal technology that Pfizer uses in the rapamune / sirolimus product provides about a 30% increase in bioavalabilty according to the research we have at the below link. You can get about the same increase in bioavailability (we believe) simply by taking the generic sirolimus with a fatty meal - as outlined in the Rapamycin Bioavailability discussion in this post. So - that is what I do:

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The results are pretty impressive and I like the idea of just taking it with a fatty meal.
Any particular company that you prefer for price,delivery, ease of communication, etc?

I have zero allegiance to any of the rapamycin online stores, in fact if anything I have a bias towards trying new ones just to test out the purchasing experience from the different vendors. I’ve purchased from about 6 of the vendors listed on our “reliable online pharmacies for rapamycin” and they’ve all come through, no hassles, with deliveries between 2 and 4 weeks from order date. Every time I order, I get price quotes from numerous vendors, and then make my decision. Prices can vary a lot over time even from the same vendor.

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Okay, good to know. I’ll take a look.

Looks like Biocon is in trouble for bribery.

https://www.fiercepharma.com/pharma/biocon-charged-bribery-scheme-influencing-regulator-skip-diabetes-drug-trial

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I have been taking for almost a year love my supplier! He takes care of my tribe! This is excellent news!

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Just curious how much lab tests cost using valisure?

It used to be a few hundred dollars, but now they’ve stopped doing lab tests for individuals, so as to focus on their own in-house pharmacy (that tests all the batches of drugs before shipping them out).

Any suggestions for alternatives in the US?

No, but I’ve searched… Its easy enough to search on “analytical lab” in your city, but they are typically expensive ($700+) for a compound analysis. I think that @Mac found a good one in Toronto, Canada that he used for some rapamycin powder he purchased - perhaps he can share the details (you can private message him in this forum). The more data we can get the better! Please post any results you might get.

Has the non-Sirolimus peak in the Biocon been identified? I am interested in ordering the Biocon because its cheaper but that other ingredient concerns me. It seems like many of you all are using Biocon and must not be very concerned about this, so i’m wondering if i’m missing something that everyone else is aware of? is there a reason I should not worry much about this?

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Not to my knowledge. I don’t think anyone else has done any testing (or at least reported any testing). Definitely an area were it would be nice to have more data, but its expensive for the analytical lab analyses.

I’m wondering how people came to the conclusion that it’s safe enough to take, considering how many use it on this forum.

I think the general test results were pretty good for most people, with the one question mark around the filler / extra spike.

I don’t know, but Biocon 1mg tablets have a little more filler material than the 1mg Zydus brand tablets and are slightly larger than the Zydus brand. Both of the white 1mg tablets contain titanium dioxide, a commonly used food, and medicine whitener.
I have used both effectively.