Glenmark Levothyroxine

[helvella]

I have just noticed some new documentation on the MHRA site for a previously unknown levothyroxine product. This is called Glenmark. Some of the MHRA documents are dated 07/09/2020.

I have no idea of the distribution plans.

The website for the UK arm is here:

glenmarkpharma.co.uk/

The Indian/international website is here:

glenmarkpharma.com/

The Wiki page for Glenmark has a little information, but isn't very revealing:

en.wikipedia.org/wiki/Glenm...

UK Levothyroxine Tablets

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Last updated 11/09/2020.

This is a list of currently marketed levothyroxine tablets in the UK.

Please note that re-branding (whether by a manufacturer or as an ‘own label supplier’) – which has happened with several products – does not mean any change to formulation.

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🔹 Accord (marketing authorisation holder) – formerly Actavis

🏭 Accord-UK (manufacturer)

🥛 contains lactose – 39.95mg in 50 microgram tablet, 54.90mg in 100 microgram tablet

  50 microgram  PL 0142/0104

  100 microgram  PL 0142/0105

🟢 50 microgram and 100 microgram PIL: mhraproducts4853.blob.core....

🟣 50 microgram SPC: mhraproducts4853.blob.core....

🟣 100 microgram SPC: mhraproducts4853.blob.core....

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🔹 Advanz (marketing authorisation holder) – branded both “Mercury Pharma Levothyroxine” and “Mercury Pharma Eltroxin” which are identical

🏭 Custom Pharmaceuticals Ltd. (manufacturer)

🥛 contains lactose – 30.49mg in 25 microgram tablet, 48.86mg in 50 and 100 microgram tablets

  25 microgram  PL 12762/0016 5.5mm diameter

  50 microgram  PL 10972/0031

  100 microgram  PL 10972/0032

🟢 Eltroxin 25 microgram PIL: mhraproducts4853.blob.core....

🟢 Eltroxin 50 & 100 microgram PIL: mhraproducts4853.blob.core....

🟢 Levothyroxine 25 microgram PIL: mhraproducts4853.blob.core....

🟢 Levothyroxine 50 & 100 microgram PIL: mhraproducts4853.blob.core....

🟣 Eltroxin and Levothyroxine 25 microgram SPC: mhraproducts4853.blob.core....

🟣 Eltroxin and Levothyroxine 50 microgram SPC: mhraproducts4853.blob.core....

🟣 Eltroxin and Levothyroxine 100 microgram SPC: mhraproducts4853.blob.core....

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🔸 Almus ‘own label supplier’ – (a brand owned by Walgreen Boots Alliance – Boots pharmacies and Alliance distributor)

  50 microgram – This is repackaged Accord – formerly Actavis.

  100 microgram – This is repackaged Accord – formerly Actavis.

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🔹 Aristo (marketing authorisation holder)

🏭 Aristo Pharma GmbH (manufacturer)

No lactose ingredient

  100 microgram  PL 40546-0159

🟢 PIL: mhraproducts4853.blob.core....

🟣 SPC: mhraproducts4853.blob.core....

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🔸 Glenmark (marketing authorisation holder)

🏭 Glenmark Pharmaceuticals Europe Limited (manufacturer)

No lactose ingredient

  25 microgram  PL 25258/0293

  50 microgram  PL 25258/0294

  100 microgram  PL 25258/0295

🟢 PIL: mhraproducts4853.blob.core....

🟣 25 microgram SPC: mhraproducts4853.blob.core....

🟣 50 microgram SPC: mhraproducts4853.blob.core....

🟣 100 microgram SPC: mhraproducts4853.blob.core....

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🔸 Northstar ‘own label supplier’ – (a brand owned by McKesson – Lloyds pharmacies and AAH distributor)

  25 microgram – This is repackaged Teva. ❗

  50 microgram – This is repackaged Accord – formerly Actavis. ❗

  100 microgram – This is repackaged Accord – formerly Actavis. ❗

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🔹 Teva (marketing authorisation holder)

🏭 PLIVA Croatia Ltd (manufacturer)

No lactose ingredient

  12.5 microgram  PL 00289/1971

  25 microgram  PL 00289/1972

  50 microgram  PL 00289/0038

  75 microgram  PL 00289/1973

  100 microgram  PL 00289/0039

🟢 12.5 and 50 microgram PIL: mhraproducts4853.blob.core....

🟢 25, 75 and 100 microgram PIL: mhraproducts4853.blob.core....

🟣 12.5 microgram SPC: mhraproducts4853.blob.core....

🟣 25 microgram SPC: mhraproducts4853.blob.core....

🟣 50 microgram SPC: mhraproducts4853.blob.core....

🟣 75 microgram SPC: mhraproducts4853.blob.core....

🟣 100 microgram SPC: mhraproducts4853.blob.core....

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🔹 Wockhardt (marketing authorisation holder)

🏭 CP Pharmaceuticals Ltd (manufacturer)

🥛 contains lactose

  25 microgram  PL 29831/0130

🟢 PIL: mhraproducts4853.blob.core....

🟣 SPC: mhraproducts4853.blob.core....

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🔹 – identifies marketing authorisation holder

🔸 – identifies ‘own label supplier’ products

🏭 – identifies manufacturers (where known)

🥛 – contains lactose

❗ – Take particular note of the actual product which varies by dosage.

🟢 PIL – Patient Information Leaflet

🟣 SPC – Summary of Product Characteristics document

🟢🟣 Single document combining typical PIL and SPC information

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Only products which definitely contain lactose are identified (🥛 contains lactose). Please always check other products. Where products are ‘own label supplier’, check the marketing authorisation holder for the specific product.

There are links to product information on the MHRA (Medicines and Healthcare products Regulatory Agency) website. products.mhra.gov.uk/ These are the latest versions known.

If there is anything inaccurate in this information, please let me know by Private Message, or on the forum:

healthunlocked.com/user/hel...

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This document is updated whenever I am aware of any changes or enhancements are needed. Please check the Last updated date. The current version is available as a PDF here:

dropbox.com/s/6h3h0qi4eqwi6...

[tattybogle]

Thank you, Helvella

[crimple]

Thanks Helvella, I tired to find info about the levo product but failed! I couldn't find a search box on the website to type in levothyroxine. I went to a page with items in alaphabetic order but no levo!! Will make a note to research when I have a bit more time.

[helvella Administrator Thyroid UK in reply to crimple]

Nor could I could find out anything else!

I decided to post anyway so that the information I have collected is accessible even before anyone gets this make dispensed.

[K1V1]

Hello Havella,

I have only used T3 hormones made by India Pharma company. It was good but now not available in India, which is strange. You can buy them in UK but more expensive than buying directly from India.

Hence, I have stopped using. Instead I buy T3 Tiromel from Turkey. My friends went for holiday last year, they bought me 4 packs X 100 tablets which lasted me whole year. Another relative went to Istanbul for a holiday 3 weeks ago & she bought me 2 X packs of 100 tablets which will last me another 6 months.

I hope this may be of to your help.

[HarlesBarles]

Thank you for posting about this Helvella. I managed to get my local pharmacy to order in Aristo and all the pains I had with Teva have gone (agonising, constant shin splints, severe lower back pain so extreme that I couldn’t walk).

I still have generalised pain and stiffness though. It is what I used to have when accidentally consuming traces of gluten, and sadly it has been constant since I started taking Thyroxine in March. I have been wondering if the stiffness is triggered by the additional ingredients in the tablet and will be keen to try another lactose free formulations. Hopefully Glenmark will be available soon!!!

[helvella Administrator Thyroid UK in reply to HarlesBarles]

Am absolutely delighted to read that.

Please would you consider filing a Yellow Card report on the Teva product?

In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) operates the Yellow Card scheme for reporting issues with medicines.

They have slightly different approaches to Side Effects, Defective medicines and Counterfeit or fake medicines. All can be accessed by following this link:

yellowcard.mhra.gov.uk/

It very important that we report issues. Although we might wish that we could rely on medical staff (doctors, nurses, pharmacists, etc.) to make reports, the truth is they often do not. Often no-one has told them of the issues they are having. Even if you know they have made a report, your report will add to the information. You will explain it differently and might include different details.

Years ago, the MHRA opened up the Yellow Card scheme to allow patients to make reports.

If in doubt, make a report. The MHRA must expect that some reports are inappropriate and will have mechanisms in place for handling them. It isn't your responsibility to make the decision. All that can reasonably be expected of you is to make reports in good faith, taking care to be as accurate as you can.

[HarlesBarles]

Thanks for the link. I definitely will do!

[130396]

I know this is old post but can you tell me if Glenmark is the manufacturer/ brand packaging , or just made and labelled for a specific pharmacy? Thank you

[130396]

helvella I know this is old post but can you tell me if Glenmark is the manufacturer/ brand packaging , or just made and labelled for a specific pharmacy? Thank you

[helvella Administrator Thyroid UK in reply to 130396]

I am still not aware that anyone has yet received any Glenmark levothyroxine product - ever.

It was licensed but, for whatever reason, appears not to have been launched.

More up to date information is here:

helvella - Thyroid Hormone Medicines

I have created, and try to maintain, a document containing details of all thyroid hormone medicines in the UK and, in less detail, many others around the world.

From Dropbox:

dropbox.com/s/shcwdwpedzr93...

From Google Drive:

drive.google.com/file/d/12N...

[130396 in reply to helvella]

helvella A lady on one of the FB thyroid groups is trying to get further supply of it as she’s had it but can’t now find a chemist that can obtain it for her .

So I just wanted to know if it was manufactured as a different brand to the usual ones

[helvella Administrator Thyroid UK in reply to 130396]

Is the lady in the UK?

Have a look in my medicines document.

One label suppliers - which is what they call Almus and Northstar - are not separately licensed. I suggest phoning Glenmark as distribution could be limited.

Glenmark – Glenmark Levothyroxine sodium tablets

Marketing authorisation holder Glenmark Pharmaceuticals Europe Limited in UK

Manufactured by Glenmark Pharmaceuticals Europe Limited

25, 50 and 100 microgram tablets are licensed but are not and, so far as I can tell, never have been, distributed in the UK.

glenmarkpharma.com/

medicines.org.uk/emc/compan...

No lactose ingredient

[130396 in reply to helvella]

Thank you very much for all that information. She said she’s had them before but now can’t source them

[helvella Administrator Thyroid UK in reply to 130396]

The best people to ask are the manufacturers - they know who distibutes them and that would guide as to which pharmacies. Or if they have decided not to bother selling them any longer, or whatever.

[130396]

Thank you. I’ve told her to contact them direct

[helvella Administrator Thyroid UK in reply to 130396]

And do let us know!

[130396]

Yes I will definitely let you know once she has replied to me