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Pharmasyntez is a Russian pharmaceutical company focused on development and manufacturing of drugs for the tuberculosis, cancer, HIV, immune system disorders treatment.
Anti-TB drugs (partial list)

  • First-line treatment drugs
    • Rifampicin
    • Isoniazid
    • Ethambutol
    • Ftivazide
  • Second-line treatment drugs
    • Cycloserine
    • PAS (4-Aminosalicylic acid)
    • Rifabutin
    • Capreomycin
    • Perchlozone (for the multidrug-resistant TB treatment)

The portfolio of generic anti-retroviral drugs (in development)

  • Saquinavir  (Interfast)
  • Darunavir (Kemeruvir)
  • Emtricitabine (Emtritab)
  • Ritonavir (Retvitset)
  • Nevirapine (Nevirpin)
  • Lopinavir/ritonavir (Kalidavir)
  • Lamivudine/zidovudine (Dizaverox)
  • Abacavir (Olitid)
  • Zidovudine (Azimitem)
  • Lamivudine (Amiviren)
  • Stavudine (Stazex)
  • Efavirenz (Regast)
  • Tenofovir (Tenvir)
  • EECA CAB urges Pharmasyntez to take all measures necessary to control the quality of its antiretroviral and anti-tuberculosis drugs (both those which are currently being produced and those that are planned for production), including adhering to the GMP standards, WHO prequalification, and pharmacovigilance; and furthermore to maintain these standards and to be open to cooperation with patient organizations on the issue of quality assurance.
  • EECA CAB believes that conducting bioequivalence studies of generic drugs in comparison with other generic drugs may produce misleading information about the actual equivalence of these drugs; EECA CAB urges the company to conduct additional studies of those drugs that were compared with other generic drugs, as well as to introduce special measures for the quality control of these drugs. At the same time, EECA CAB welcomes the readiness of the company to provide the results of the bioequivalence study to experts from the patient community.
  • EECA CAB urges Pharmasyntez to set the prices of generic antiretroviral drugs at a significantly lower level than the prices for the original drugs in order to help reduce treatment cost and to expand access to antiretroviral therapy.
  • EECA CAB recognizes the importance of the company’s achievement in the development of new drugs for multidrug-resistant tuberculosis given the limited selection of options, namely, developing and launching the drug «Perchlozone». However, EECA CAB believes that Pharmasyntez must take measures to ensure that the results of the clinical trials of the drug «Perchlozon» are presented to the international scientific community, including publishing the results in internationally recognized scientific journals, and submitting applications to strict regulatory agencies. EECA CAB believes the data currently available is not sufficient to evaluate the safety and efficacy of the drug «Perchlozon» in full measure.
  • EECA CAB urges Pharmasyntez to include a representative from one of EECA CAB’s community organization members in the ethics committee of the phase IV clinical trials of the drug «Perchlozone», as well as to conduct further consultations with the patient community, including EECA CAB, on the interim results of the phase IV trials for «Perchlozone».
  • EECA CAB urges Pharmasyntez to conduct post-marketing studies of the drug «Perchlozone» on a regular basis as well as any other studies necessary for accumulating evidence on the safety and efficacy of «Perchlozone». These studies should include drug-drug interaction studies of «Perchlozone» with antiretroviral drugs for HIV treatment, new drugs for the treatment of multidrug-resistant tuberculosis and substitution therapy drugs which are widely used in the EECA region.

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