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

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.

So it could be filler, which may be innocuous? Thank you, I didn’t realize that. I was assuming the test results pick up active ingredients and therefore potentially dangerous and / or toxic. I listened to an interview with the author of Bottle of Lies and there was at least one antidote of a generic that had a toxic agent and that is what came to mind.

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I have been getting multiple quotes for sirolimus 1mg tablets from many sources on IndiaMart. Lowest is consistently Siroboon1 (was Sirokem) by Kachhela, then Rapacan by Biocon, and highest is Siromus by Zydus at about twice the price.
I was favoring the Biocon or Zydus due to the above posted positive lab test quality reports, then decided to ask about lab reports for the Kacchela Siroboon1. I was surprised to be sent a quite recent lab report by Iosis Remedies PVT Ltd, which indicated very positive analysis with an Assay result of 1.0089 mg.
I shall be ordering 300 Siroboon1 tablets tomorrow for the family direct from Kacchela Medex.

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I know nothing about his manufacturer… so have no specific info to share.

From the web:

Iosis Remedies Private Limited - Manufacturer of pharmaceutical injection, pharmaceutical tablets & anti cancer tablets since 2020 in Solan, Himachal Pradesh.

More info: IOSIS REMEDIES PRIVATE LIMITED - Company, directors and contact details | Zauba Corp

A new company, which from my personal experience in manufacturing, suggests a company that probably does not have the quality control systems in place that a larger, well established firm might have (just generalizing from technology manufacturing businesses I’ve been involved in.) I mean - I trust the manufacturing of https://www.agilent.com (formerly a Hewlett Packard Division) that has been producing lab/mfg technical equipment for years over a startup of two years. It takes a long time to build up really good quality control systems and supplier relationships, etc.

I also find it strange that in 2022 that this company does not seem to have a website. Certainly not one I can easily find. What type of company in this day and age doesn’t have a good website?

I’m pretty skeptical of company-provided COAs. Why would we trust them? There is a long history of Indian Pharma companies faking their data and the FDA doesn’t check on international manufacturing operations in any rigorous fashion. See the Katherine Eban’s book “Bottle of Lies”…
see here: 'Bottle of Lies' Author Katherine Eban Warns Of Purity Concerns In Generic Drugs : Shots - Health News : NPR
and here: Book Exposes How Some Generic Drugmakers Ignored Safety And Committed Fraud : NPR

This is why I like to see 3rd party lab analysis done on products. Like the one at the top of this thread, even if its only for a single datapoint. While the risk is likely quite low, we really have very little information to go on regarding quality of generic drugs in general (my belief after reading Eban’s book). And this lack of confidence is both on generic drugs we purchase in the US and India.

Others here likely have different opinions. This is just mine.

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I got my supply from Kacchela and have evidence via an unobtrusive measure that their product is the real deal. My only complaint was that he shipped it in such a way that it required a signature from the addressee or it goes back to the government, maybe Customs. Since I move around quite a bit visiting and whatnot, that’s a problem. Fortunately, I was home that time. I recently received other medicines from India that required no signature and arrived quicker.

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In virtually all shipments from India you want to make sure to use indiapost / speedpost EMS for the shipping of medicine.

Otherwise you will need to provide a prescription to the shipper.

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Kachela Medex informs me: " We send shipments to UK by RMS as we have faced some issue while sending shipments to UK via EMS. They seized a few of our shipments via EMS & we
haven’t faced any issue with RMS ."
I hope I get my order to the UK okay…

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Is Rapacan the same as Sirolimus, just a different name for the same product?

I know it can be confusing… Here is a list of all the naming conventions Rapamycin, Rapamune, Sirolimus and Other Naming Conventions

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Yes. Rapacan is Biocon’s brand name for sirolimus. It is a trusted brand.

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Hi, does anyone know which Indian online supplier sent the Biocon Sirolimus and Zydus Sirolimus that was tested at the Valisure Lab?

Hi @lifeshere , welcome to the forums and thanks for posting. The person who sent me that data on the lab test by valisure says he didn’t track the specific Indian online pharmacy he ordered that batch from, he orders from many of the different vendors.

Ultimately, I don’t think the specific reseller of the drug matters much, as its the manufacturer that we are primarily concerned about. The manufacturer’s product should be the same product no matter who sells it to you - so I don’t put much thought into the reseller, other than the pricing and how long they take to deliver the product.

So - I wouldn’t worry at all about the specific reseller.

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RapAdmin, I have faith in the trusted pharmacies listed on this site, but could a counterfeiter manufacture fake drugs and package them in look-alike packages for the Biocon or Zydus or some other brand, then become a source for an Indian pharmacy that exports internationally? I suspect if the profit was good enough for both the counterfeiter and a shady pharmacy that it could be done. A Google search for “PubMed fake Indian drugs” will produce several research articles on the subject. However, as I said, I trust the pharmacies listed on this site because I believe the contacts for these pharmacies want to maintain a long-term business based on trust.

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I strongly think that if you’re going to go through all the trouble of making a counterfeit drug, that you’d do it for higher priced, non-generic drugs not cheap generic drugs like rapamycin (that is used by a very small percent of people (i.e. mostly organ transplant patients of which there are only about 25,000 per year). They’d go for the blockbuster drugs that are still on patent (e.g. Viagra back in the day before it went generic).

I really doubt that anyone is going to waste their time with doing a counterfeit version of rapamycin. For the same effort they could make a counterfeit drug that sells for a much higher price (most brand name drugs sell for 10 to 100X the price of the generics), and thereby make a lot more money for the same effort.

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