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

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?

It was cheap - about $150 at the time, but they no longer offer it to end customers, and are instead focusing on their pharmacy business.

Now, its hard to find lab tests that are anywhere as close to as comprehensive for 10 times the price.

Siroboon is the brand name of rapamycin marketed by Kachhela Medex. It’s manufactured by Iosis Remedies. And Iosis Remedies is affiliated with Ikon Remedies. It’s their manufacturing facility.

From Ikon’s website:

Our manufacturing unit, Iosis Remedies at Nalagarh, is a GMP certified unit and accredited by an ISO 9001:2008 certificate. The state-of-the-art manufacturing facility empowered by world class machineries and skilful workforce ensures the manufacturing of world class products. We follow stringent quality control procedures at every step right from the purchase of raw material till the dispatch of finished goods.

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Iosis Remedies Private Limited is a 2 years 5 months old, private Indian Company, registered at Nagpur with a paid-up capital of Rs.1000000.

This was just one test that was done in 2019, and it looked a bit dodgy even then. Any updates on more reliable generics, or on affordable testing options now that Valisure is out of the game?

Also, what about everolimus?

Thanks,

No updates that i am aware of. And none at all done on everolimus. Yes, far from ideal testing. Please post if you do any testing.

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I am trying to figure out which labs are safe, and found this info regarding Dr Reddy’s. This was a few years ago, and I wonder how widespread this is, and whether any action has been taken to address quality control: https://www.fiercepharma.com/regulatory/dr-reddy-s-blasted-warning-letter-for-hiding-existence-of-testing-lab-from-fda

Still happening. Dr. Reddy’s is a mess.
Indian drug firms struggle with quality issues: Chemical & Engineering News

https://cen.acs.org/articles/95/i32/Dr-Reddys-struggles-meet-FDA.html

Dr. Reddy’s Recalls Prescription Drug Blister Packages Due to Risk of Poisoning

As our Administrator says in the opening post:

Yes - I’d avoid Dr. Reddy’s if possible. Zydus and Biocon seem to have a better track record.

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Who is your provider please?

I bought Zydus from NIBA Healthcare. It’s the only Indian supplier I have used. I have successfully purchased twice. Last time was a 2 year supply.

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I bought 400x1mg of Biocon Sirolimus for $262 including shipping in May 2023 from India. It took about 3 weeks to arrive. That’s about 65 cents per mg or about $21 per month @ 8mg per week. It arrived in one package with 40 boxes of 10 pills each in elaborate foil packages with manufacture date of March 2023 and expiration date of February 2025. I paid via Wise.com. That was from the following company:

“We have Rapacan (Sirolimus 1mg) tablets by Biocon (US FDA approved company) costing 160 USD for 200 tablets and 262 USD for 400 tablets. Price includes shipping charges. You can make a T/T wire transfer to our Bank account or through www.wise.com using a card. For any details feel free to contact me.
Regards
Girish Bhattad
Forveda Online Private Limited
Mobile/Whatsapp: +918329187929”

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