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

Many people like the low price of rapamycin / sirolimus from India (typically about $1/mg, or $40 per month for common dosing) but are concerned about quality. Below is a lab test report on India-sourced Biocon Sirolimus and Zydus Sirolimus that evaluates purity and checks for contaminants.

These test results were quite good, I think most people would say. This is just one test that was done in 2019, so I’m not sure how representative it is.

More broadly there are some reasons to be concerned about all generic drugs whether purchased in the USA, or India or Europe (because ultimately most of them are manufactured in India and China) - as outlined in Katherine Eban’s book. Read up here on the broader issues of quality of generic medications.

Below is the Valisure Lab test on rapamycin / sirolimus. If you have another lab test of rapamycin, please post it below (you can just add it as an attachment to a post). It would be great to have more examples like this.

Valisure_Report_191217319401.pdf (354.9 KB)

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You got a little more value for your Rapamycin in that batch lol

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This report gives me more confidence in these brands.

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As I said in a previous post: The Rapacon/Rapacan tablets contain titanium dioxide. This is why they are white. The Zydus tablets do not contain titanium dioxide that is why they are tannish/brown.
Pfizer tablets contain titanium dioxide.
While titanium dioxide isn’t considered as safe as it once was, you have been taking it your whole life in both prescription and over-the-counter meds, bakery products, candy, etc.

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my Zydus pill color are white. they contain titanium oxide. I dont know how you get the brown color pills. see the photo of the Zydus box stating color: Titanium dioxide

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I don’t know. The ones a friend of mine obtained were quite tannish. The lab report from Valisure shows a peak from the Biocon test that didn’t appear on the Zydus brand. I guess I made the erroneous assumption that it was probably the titanium dioxide. Here is a picture of the Zydus tabs I saw. It appears that the 1mg pills are white and the other strengths shades of brown. But, in any case they use titanium dioxide to make the pills white.
https://www.americanpharmawholesale.com/store.php/AmericanPharmaWholesale/pd9059473/rx-itemsirolimus-05mg-tab-100-by-zydus-pharma

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OMG, your friend’s 100 0.5 mg Zydus brand sirolimus sells for $600!

the Zydus 1mg i bought average cost per pill is about $1.50
The Pfizer Rapamune 1 mg i bought average cost per pills is $5.00

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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:

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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