Beware of cheaters: Sophisticated cinquefoil products in the pharmaceutical market

Sanitary-Epidemiological Conclusion

The market launch of ENDONORM® with the active substance Albinin® isolated from cinquefoil (Potentilla alba) root extract caused numerous attempts to create a similar thyrotropic product.

In particular, a cheap copy with a similar name Ендонорм (Endonorm) emerged in 2010 in Ukraine [1], being manufactured by a certain Kyiv company named Вітера (Vitera). A look at the composition and the Package Leaflet [2] of the Ukrainian product immediately reveals a striking similarity with the composition of the original ENDONORM® (ЭНДОНОРМ®), and clear plagiarism is apparent from the description of the effects of its components.

Instruction of application of "Endonorm" from company "Vіtera"

Still, the most important differences become evident upon careful analysis of the text of the Summary of Product Characteristics approved at the State Registration [3] of this parapharmaceutical product.

The first line in the description of the composition of this "dietary supplement" reads very plainly: екстракт коріння перстачу гусячого. This means in English, PAY ATTENTION (!): silverweed (Potentilla anserina) root extract!!! This means that the Vitera deal makers registered a product containing silverweed root extract at the State Registration and proceeded to manufacture it, but the label and the Package Leaflet [2] include a patently false statement that the composition contains white cinquefoil extract (екстракт коріння перстачу бiлого).

Approved text of the instruction for the state registration

One could presume that some unfortunate mistake crept into the documents and that Vitera manufactures a quality white cinquefoil root extract product (although apparently a copied one). All doubts were resolved, though, by chromatographic analysis of the Ukrainian counterfeit. Not even a trace (minimum quantity) of Albinin® (the active ingredient behind the thyrotropic activity of extracts from white cinquefoil root) could be found in the composition of the commercially available product (Batch 0310).

The latter fact permits a final, absolutely certain conclusion that the composition of this poorly copied fraud contains NO white cinquefoil, i. e. no root and rhizome powder, not to mention an extract.

Conclusion

The Ukrainian "Endonorm" is a surrogate copy of the original Russian product. The manufacturer, Vitera partnership, deliberately misleads consumers by disseminating this patently false information about the composition of its product.

Beware of frauds!



When you buy ENDONORM®, please pay your attention to the following:

  1. The "Manufacturer" section of the label should read MiraxBioPharma CJSC.
    MiraxBioPharma CJSC is the authorized pharmaceutical company manufacturing ENDONORM® by the order of Fitopanacea LLC;
  2. After you unscrew the cap from the polymeric bottle, you should see a disposable protective plastic peg. The absence of a plastic peg (or cottonwool placed instead) shows that the bottle has been opened before or that the product is a fraud;
  3. The authentic ENDONORM® product has a double-layer label. The outer layer covers a second one that contains English and Kazakh versions of the Package Leaflet;
  4. The left bottom part of the label contains a field with the following information: batch number, date of manufacture, and shelf-life (in the lines "BATCH No.", "DATE OF MANUFACTURE:" and "EXPIRY DATE:"). The information in these lines should be machine-printed with a characteristic hot stamping technique. If the information on the batch number, date of manufacture, and shelf-life is printed, it is a sign of counterfeiting!
  5. Beginning from February 2015 (Batch 22), ENDONORM® is supplied in white-blue gelatin capsules (due to a change of capsule supplier).

If you see ENDONORM® without the distinctive features described above or in a different, suspicious package, please notify us by emailing to: fraud@fitopanacea.com.