Country
🇷🇺 Russia
Regulator
Federal Service for Surveillance in Healthcare (Roszdravnadzor)
Capital
Moscow
Region
CIS
Currency
Russian Ruble
Official Lang.
Russian
Dial Code
+7
ISO Code
RU

Supply & Market

Russia is the dominant pharmaceutical market in the CIS and the gateway to the Eurasian Economic Union (EAEU) common-pharmaceutical-market — a unified registration framework spanning Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan. Taj Pharma supplies DEFRATAJ Deferasirox dispersible tablets through Russian MAH partners with EAEU-format dossiers, supporting both the federal VED (Vital and Essential Drugs) list inclusion and regional Ministry-of-Health hospital tenders.

Russian thalassemia caseload is concentrated in the North Caucasus republics (Dagestan, Chechnya, Ingushetia) and the Krasnodar Krai region. The federal "7 Nosologies" high-cost-medicines programme covers iron chelation for transfusion-dependent patients, with consolidated procurement run through Roszdravnadzor and the Ministry of Health. Our Mumbai team prepares EAEU-format Module 1 with Russian SmPC, listki-vkladysh patient leaflets, and Cyrillic secondary packaging.

Logistics from JNPT (Mumbai) to St. Petersburg run 30–38 days via Cape of Good Hope (post-Suez disruption); alternate routes via Vladivostok (Trans-Siberian) and Novorossiysk (Black Sea) are also supported. Cold-chain is unnecessary for dispersible tablets, but climatised containers can be arranged for Trans-Siberian winter routes to keep ambient transit above -20°C as a precaution.

Supply Capability for Russia

DEFRATAJ ships to Russia with full Cyrillic / Russian-language labelling, EAEU-format secondary packaging, and Crypto-Code serialization (Honest Sign / Chestny ZNAK) for the Russian Federal Drug Track-and-Trace system mandated under FZ-381.

  • Strengths: 100 mg, 125 mg, 250 mg, 400 mg, 500 mg dispersible tablets
  • Pack formats: HDPE bottles (30/60s), Alu-Alu blisters (10x10), VED-tender institutional packs (100s) with Crypto-Code DataMatrix
  • MOQ: 100,000 tablets per strength for VED / "7 Nosologies" tenders
  • Lead time: 5 weeks ex-Mumbai · 30–38 days transit to St. Petersburg / Novorossiysk
  • Documentation: CoA, CoO, packing list, BL, EAEU-GMP certificate, free-sale certificate (consularised), Russian-Apostille declaration, batch protocol, Cyrillic SmPC + listki-vkladysh
  • Track-and-trace: Honest Sign Crypto-Code per pack, aggregated to case and pallet level
  • EAEU re-export: single dossier covers Belarus, Kazakhstan, Armenia, Kyrgyzstan once Russian registration is approved

Regulatory Pathway in Russia & the EAEU

Drug registration in Russia is handled by Roszdravnadzor (Federal Service for Surveillance in Healthcare) under EAEU Decision No. 78 (the unified pharmaceutical market regulation). Taj Pharma submits the dossier in EAEU-CTD format (Russian Module 1, English/Russian bilingual Modules 2–5) with bioequivalence data referenced to the EU originator and Zone IVa/IVb stability data covering Russian climatic conditions.

Standard EAEU generic registration runs 14–20 months; priority review applies for VED-list and "7 Nosologies" inclusions. EAEU-GMP inspection of the Indian plant is conducted by FSI (Federal State Inspectorate) — we have a current EAEU-GMP certificate on record. Pharmacovigilance reporting follows the EAEU PV Module with Russian-language ICSRs submitted to the AIS Roszdravnadzor portal within 15 days for serious-unexpected reactions.

  • EAEU-CTD with Russian Module 1 prepared
  • Current EAEU-GMP certificate on record (FSI inspection)
  • Bioequivalence vs. EU originator on file
  • Zone IVa/IVb stability covering Russian climatic range
  • Honest Sign / Chestny ZNAK Crypto-Code serialization compliance
  • ISO code RU · trade currency Russian Ruble (RUB)
  • Single dossier covers EAEU member states (BY, KZ, AM, KG)

Other Markets in CIS

Ukraine SMDC
Belarus BICCM
Uzbekistan Uzpharm
Kazakhstan NCEDS
Kyrgyzstan DDFP
Azerbaijan AIEM