Good news on generic empagliflozin - I bought a bunch of the original brand name empagliflozin from India through Jagdish, should last me for 3-4 years. I hate to even bring it up, so forgive me, but is nobody even slightly wondering if the generics are going to be 100% equivalent to the brand name originals? Over and over again we’ve had cases where that didn’t transpire to be the case. I have no reason whatsoever to suspect that the generics are not going to be 100% on the up and up, so great news. But - and this is just me - if I can easily afford the brand name originals, as I have been able so far, I don’t mind paying a bit more for peace of mind… of these companies, I’m only familiar with Dr. Reddy’s, which is sometimes in the news with dodgy drugs… the others, I don’t even recognize. I’m sticking with what I know, the original maker… pay more, fine. YMMV.
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Generics by definition are equivalent to brand name drug, but for Indian generics, it might not be true (lower standards compared to the USA/UE). I don’t think it is a big problem for us because if the indian generic has a lower absorption rate, or a bigger Cmax or whatever, it will not the change the outcome. The therapeutic window isn’t small.
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The biggest issue, I think, with Indian generics are contaminants like nitrosamines that get into the drug manufacturing process when companies re-use solvents that are frequently used in the manufacturing process (to save money). This cost-cutting effort results in higher levels of nitrosamine residues in the final packaged drugs. These are cancer-causing agents.
The broad risk of nitrosamine impurities
Nitrosamines are a group of chemical substances, some of which can pose a risk to patients and public health due to their mutagenic properties. When they are metabolized, nitrosamines are converted to alkylating agents. Some of these are known to damage DNA and have been linked to cancer.
Unacceptable levels of nitrosamine impurities in some batches of the angiotensin II receptor blocker (ARB) valsartan were first detected in 2018. Subsequently, they were found in other ARBs, as well as unrelated drugs, including ranitidine, nizatidine, metformin, rifampin and rifapentine.
Finding nitrosamines in several drug products that contain drug substances with diverse chemical structures indicated that there could be multiple sources of nitrosamine impurities, including other components of drug products as well as the manufacturing process itself.
Sources of nitrosamine impurities
Extensive investigations determined that unacceptable nitrosamine levels found in valsartan were caused by a change in the manufacturing process that had been made to improve product yield. Nitrosamines can arise throughout the drug manufacturing process, including synthesis, purification, formulation, packaging, and storage. Even small changes to manufacturing processes can introduce new or changing levels of impurities. They can be introduced in raw materials, solvents, or result from product degradation. With so many possible sources for nitrosamine impurities, manufacturers should establish control strategies to evaluate and mitigate potential risks. When the risk of nitrosamines is identified, the use of analytical testing to detect and measure nitrosamine levels is vital to protect patients from exposure to unacceptable levels of these potentially harmful substances.
https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/information-health-product/drugs/nitrosamine-impurities.html
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adssx
#1447
Dapagliflozin for Small Nerve Fibre Regeneration in Diabetic Peripheral Neuropathy: A Randomised Controlled Study (DINE) 2025
In this prospective, open-label, randomised, controlled study, 40 participants with DPN were randomised to receive add-on 10 mg dapagliflozin OD (Group A) to existing oral antidiabetic drugs (OAD) (n = 22) or continue OADs as a standard of care (Group B) (n = 18). Participants underwent assessment of neuropathic symptoms and signs (MNSI), vibration perception threshold (VPT), corneal confocal microscopy (CCM) to quantify corneal nerve fibre density (CNFD), corneal nerve branch density (CNBD) and corneal nerve fibre length (CNFL) and skin biopsy to assess intraepidermal nerve fibre density (IENFD) and plasma markers of oxidative stress at randomisation and after 6 months.
HbA1c decreased in Group A (p = 0.002) and Group B (p = 0.003), with no change in weight, body mass index (BMI) or lipids. Total MNSI increased in Group A (p = 0.01) with no change in Group B (p = 0.06). IENFD increased significantly in Group A (p = 0.01) and Group B (p = 0.01), while CNFD (p = 0.002), CNBD (p < 0.001) and CNFL (p = 0.025) increased in Group A with no change in Group B. There was a significant increase in glutathione peroxidase (p = 0.02) in Group A with no change in Group B, and a decrease in malondialdehyde in both groups (p < 0.001).
In participants with T2DM and DPN, dapagliflozin was associated with small nerve fibre regeneration and improvement in markers of oxidative stress.
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man_li
#1448
Buy empagliflozin, dapagliflozin, and canagliflozin from India. Do you have any recommended manufacturers or brands?
thanks.
Generally, any of the major companies, see: Generally Good Indian Pharma Companies
You can even get what I believe is the brand name drug for Empagliflozin ; from Boehringer Ingelheim for good prices…
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Yes. Jardiance is not a generic. You can get the real deal from India at great prices. That’s what I do.
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Right now I get Sun Pharma Dapagliflozin as it’s a lot cheaper than the Jardiance I was getting before. I see little reason to pay significantly more for Jardiance but I may switch back to empagliflozin if the new generics are cheaper.
Sun Pharmaceutical Industries is the world’s fourth-largest speciality generic pharmaceutical company and India’s top pharmaceutical company. (according to a business-standard.com article), So I’m hoping that means they won’t be cutting any corners.
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I like Sun Pharma as well. They are my go to for Indian generics along with Zydus. I buy my Bempedoic Acid + Ezetemibe (Brillo EZ) from Sun Pharma.
That is a shame. I also take Brillo EZ like many members here. I’ve got no idea how serious a breach this is for sun pharma, given their size, or whether it’s just indicative of generally poorer standards in India. I guess at least there are some checks happening. Still not nice to read either way. Maybe it’s time for a rethink.
I also use Tretinoin from Healing Pharma who don’t have the best reputation but it’s the only brand I’ve seen being used - Does anyone use another brand from India? Their topical minoxidil was really nasty stuff that made me smell like an alcoholic - I have to specify the Zeelab brand when buying minoxidil.
I must admit I haven’t done a deep dive into each brand and their safety profile.
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I recommend Zydus whenever possible as an option.
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Jjazz
#1456
Nitrosamines are formed from secondary amines present in the structure of the drug. Since drugs like empagliflozin and canagliflozin don’t contain secondary amines, they are at very low risk for containing nitrosamines. There is still some minimal risk that nitrosamine containing excipients are added to the pills, but this hasn’t typically where the exposure comes from. So for this class of drugs, I don’t worry about it.
For others, like PDE5 inhibitors (which contain secondary amines) there is more reason to be concerned.
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adriank
#1457
All I can say is since I started taking jardiance 25mg in the morning and acarbose 100mg during my lunch and dinner and metformin 1000mg at dinner… Within 4 weeks my hba1c dropped. My uric acid level went from 0.55mmol to 0.39mmol. This is the first time in 15 years my uric acid is below the high range. The feeling is almost immediate. I can now use my ankle much more easily than before. I’m aiming to reduce the uric acid to 0.25mmol range and my hba1c to about 5%.
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I’ve tried adding metformin to Jardiance and acarbose but found it made me really exhausted in the mornings and generally weaker. I stopped taking it because these side effects were tough to handle, but I’m unsure if it’s worth persevering to see if they’d fade over a few weeks. I’m also uncertain about the additional benefit metformin would provide on top of the two medications that already agree with me well.
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adriank
#1459
I didn’t feel any of the side effects so I’m quite happy with them.
I had a similar experience, but with Canagliflozin, and then I switched to empagliflozin and don’t seem to have the issue. You might try one of the other SGLT2 inhibitors. Plus - you may be getting your blood sugar levels too low, which could impact your energy levels. Perhaps trial only one at a time for a few weeks.
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adriank
#1461
Yes I forgot to mention that you probably should have a glucose monitor to check that you are not depleting your sugar level. I have a chocolate addiction so … I am not saying you should eat large amounts of chocolates… maybe take 12.5mg instead of 25mg. My HBa1C was on the high side of 6.7% so I needed it to come down.
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What sort of chocolate. I can get 85% cocoa chocolate from my local co-op. Sadly today they had run out so I have had to settle for 70%.
adriank
#1463
I love the milk choclate… not into dark chocolates… LOL. I take between 100mg to 200mg of melatonin at night before I sleep. My sleep has improved from previously… but possibly lots of other factors.
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