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

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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I agree, I think we’re safe for now. Rapamycin is not a big seller relatively speaking and it wouldn’t be worth the effort at this point. That said, if rapa goes mainstream it could become a real issue:

What’s the most counterfeited drug in the world?
In terms of revenue, I would say Viagra or Lipitor. In terms of numbers, I would say probably malaria pills or antibiotics. In 2014, Interpol did a massive raid in Angola and they found 1.4 million packets of substandard malaria pills, which were enough for the entire country. Every single one of them was fake.

Yes - the rapamycin market is a tiny market by most measures. Only about 25,000 people get organ transplants in the US per year (perhaps a few hundred thousand world-wide) - and the longevity market is perhaps in the range of a a few thousand up to maybe 10,000 people globally. So - hardly a good target for drug counterfeiters. Perhaps when the drug becomes popular like viagra.

But even that article you pointed to noted:

How much of this substandard drug problem is deliberate criminal counterfeiting versus sloppiness?

I think deliberate counterfeiting is relatively small. It gets more press because it is more sensational, but I think the problem of substandard, fake, or “sloppy” is bigger. And sloppiness comes in various forms. One is cutting corners because you can get away with it—instead of carrying out ten steps of cleaning, you would carry out eight, and nobody checks. And then there is this issue of degradation because the drug was meant to be in cold chain and it’s sitting on a tarmac in the Middle East for 48 hours.

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I just received my first batch of Rapamycin and was excited to take my first dose. However, Amazon Pharmacy did a bait and switch on me. They pictured the Pfizer version with the coating but I was sent the Glenmark version. It says that it’s coated and looks like it has some coating on it but I had heard that it’s not and there are issues with absorption of non-coated pills. It’s also a generic which is not my preference with this drug. I’m on the fence on what to do now. I can’t ship them back. Has anyone had any issues with the Glenmark version? Anyone tested the absorption with a blood test? Thanks.

I think you’re fine. The bioavailability issue that people have found is the powder capsules sold by compounding pharmacies. The generic tablets are fine, from everything I’ve heard.

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What are the compounding pharmacies?

I am thinking of placing an order for Kachhela rapamycin now…

Alex - not sure what you’re asking here… are you asking “what are compounding pharmacies”?

They are very different than the generic medications manufactured by companies like Biocon, Zydus or Kachhela… which are manufactured in mass quantities and sold as a uniform product (hopefully) around the world.

What’s an example of compounded rapamycin?

Here is an example of a compounding pharmacy in the USA. They are pharmacies make their own products (instead of buying the drugs from the pharma companies). They buy the raw rapamycin powder from some source (probably china) and use other compounds to then package it in a capsule. This is the type of product that people have had problems with in terms of its bioavailability… Bioavailability of Rapamycin From Compounding Pharmacy

What was the cost of doing this lab purity test through Valisure?