Russian Pharma Market in Focus: Structure of Medicines Manufacturing Licenses

By 2026, the Russian pharmaceutical industry has formed as a mature and stable system. An analysis of licenses listed in the Unified Register of Medicines Manufacturers, based on data from the Ministry of Industry and Trade, demonstrates the completion of the period of extensive growth and a transition to a phase of qualitative stabilization. The market is characterized by high manufacturer discipline and a clear geographical structure.

Scale and Stability: The “Saturation Effect”

According to official data as of January 13, 2026, there are 553 active licensees in the Russian Federation, managing 1,022 production sites across 78 regions of the country.

A detailed analysis of the license sample confirms the high reliability of the sector: 96% of documents (501 items) have an “Active” status. The share of suspended licenses is only 4%, and in most cases, this involves temporary suspension to address violations or for re-registration, indicating a functioning control system.

The dynamics of license issuance reflect key stages of the industry’s development:

  • Investment Peak (2011): 39 licenses issued at the start of the “Pharma-2020” program.
  • Response to Challenges (2020): A spike to 31 licenses amidst the pandemic.
  • Stabilization (2023–2025): The indicator has settled at a level of 15–22 licenses per year.

Experts characterize the current stage as a “saturation effect”: the market is filled with players, and the focus has shifted from opening new legal entities to modernizing and expanding the competencies of existing plants.

Geography: Balance Between the Center and Regions

The industry maintains a historically established concentration in the “Capital Cluster”. Moscow, the Moscow Region, and St. Petersburg collectively hold about 40% of all production licenses:

  • Moscow — 23% (120 licenses);
  • Moscow Region — 10% (53 licenses);
  • St. Petersburg — 7% (37 licenses).

Nevertheless, according to the Ministry of Industry and Trade, the presence of sites in 78 regions of the Russian Federation confirms the industry’s deep penetration into the regions. Production centers have formed in the Vladimir, Kaluga, Novosibirsk, and Sverdlovsk regions, which reduces the risks of logistical centralization.

Structure of Activities

An analysis of the license content reveals a typical operating model for a Russian pharmaceutical manufacturer. The standard “license package” includes three key elements mentioned with equal frequency (~90 times in the sample): production, storage, and sales. This indicates the license structure as a comprehensive document covering the cycle from manufacturing to distribution.

Such integration creates economies of scale for major pharmaceutical companies and allows vertically integrated manufacturers to control the entire spectrum of activities. However, this can also lead to a dilution of focus — a company may be licensed for production but, in reality, engage mainly in the sales of finished products.

The API Challenge

A special place in the structure is occupied by the production of pharmaceutical substances (Active Pharmaceutical Ingredients – API). This type of activity accounts for about 12% of mentions in the register.

This indicates that the vast majority of licensed facilities are engaged in secondary processing — obtaining finished dosage forms from ready-made or semi-finished components that are imported or obtained from other sources, while the synthesis of active substances remains a niche for specialized sites. Nevertheless, state import substitution programs aim to gradually increase this share in the future.

Key Conclusions

The License Register of the 2026 sample reflects a mature but incomplete pharmaceutical ecosystem. On one hand, the high share of active licenses indicates the reliability of the regulatory system and the adaptation of manufacturers to strict standards. On the other hand, we see structural imbalances:

  • Geographical concentration in the capital cluster;
  • Acute shortage of active pharmaceutical ingredient production;
  • Decrease in licensing rates.

The state import substitution policy, launched back in 2008, provided a base, but achieving real pharmaceutical sovereignty requires a transition from “packaging” to synthesis. The challenges facing the industry require the synchronization of state and business efforts precisely in the deep processing segment.

All this data is available for independent analysis in our new service — Unified Register of Medicines Manufacturers.

Check the Medicines Manufacturing License

The complete list of licensees with details by type of work is available in our registry.

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