From Russian API to finished dosage form: NCSS is building a full pharmaceutical development cycle

GxP News: Andrey Arkadyevich, in recent years the Russian pharmaceutical industry has developed primarily under the banner of import substitution. In your view, where do we stand today?

Andrey Berman: I would say that import substitution has performed — and continues to perform — an extremely important function, but today the industry faces a more complex task. We need to move from replacing individual imported products toward a sustainable national technology base — the ability to develop a product ourselves, obtain the API, create the finished dosage form, scale the technology, ensure quality control, and accompany the product along the regulatory pathway.

For the pharmaceutical industry it is especially important that the state objective is no longer framed simply as the existence of a Russian analogue. The national project “New Health Preservation Technologies” sets the goal of technological sovereignty in medicines manufacturing, and one of its benchmarks is that by 2030 strategically important medicines produced in Russia on a full cycle — including synthesis of the pharmaceutical substance — should reach an 80% share.

In my view, this is where the industry’s main challenge lies today: it is not enough to replace a supply; we need to build inside the country a resilient chain of knowledge, technologies, analytical competencies and industrial manufacturing. And it is into this chain that we at NCSS are consistently integrating ourselves.

GxP News: How is NCSS responding to this new agenda? Many specialists still primarily associate the company with reference materials.

Andrey Berman: And that is entirely natural, because our story began precisely with reference materials. But from the very beginning we viewed reference materials not as an isolated product, but as an element of the pharmaceutical industry’s quality infrastructure.

Over several years the company has undergone a very significant evolution. A modern laboratory complex appeared, analytical competencies developed, and a quality management system was implemented. As of 2026, the NCSS portfolio exceeds 270 reference material items, and in April of this year we opened a full-cycle R&D center focused directly on developing approaches to API synthesis and creating finished dosage forms.

Today our task is to offer pharmaceutical companies not a set of disconnected laboratory operations, but a single project contour in which scientific development is oriented from the outset toward subsequent industrial implementation and regulatory requirements. That is exactly the model we embedded in the R&D center.

GxP News: Let’s unpack this model in practical terms. Suppose a Russian manufacturer already has a domestic pharmaceutical substance and wants to create a finished dosage form on its basis. What can NCSS offer such a customer?

Andrey Berman: This is one of the basic operating models of our R&D center. Having a domestic API is a very important result, but by itself it does not yet mean that we have obtained a finished industrial medicinal product.

Our R&D center is positioned as a full-cycle development platform. In particular, we work on creating dosage forms with account of the substance’s biopharmaceutical characteristics and can address challenges related to low solubility, bioavailability or stability. In parallel, the analytical part of the project takes shape — methods are developed and validated, an approach to quality control is defined, and the impurity profile is studied.

GxP News: And if there is still no Russian industrial technology for obtaining the API itself?

Andrey Berman: Then we can enter the project at an earlier stage.

Work begins with analyzing the molecule and possible synthetic approaches. Next comes development or optimization of the API production scheme, selection of conditions, work with starting materials and intermediates, purification and product isolation. A very important part is the impurity profile: it is necessary to understand which impurities form, how to identify them and how to control them. The NCSS R&D center includes development and optimization of synthetic schemes, process scale-up from laboratory to pilot level, identification and synthesis of impurities, and formation of their profile.

This is where one of NCSS’s historically strong competencies comes into play. The company works with reference materials of active substances and impurities, and the analytical infrastructure makes it possible to link chemical development with quality control. Thus the synthetic chemist, the analyst and the specialist in the future finished dosage form work not as three independent contractors, but as parts of one project.

GxP News: So NCSS can engage both in API development and in the subsequent creation of the finished dosage form?

Andrey Berman: Exactly. And we see this as one of the main advantages of our model.

For a notional project there can be two entry points. First: the customer already has a Russian API and needs to create a competitive finished dosage form on its basis. Second: there is a selected molecule and a need for localization, but first it is necessary to create or optimize a Russian API synthesis technology.

In the second case the trajectory is as complete as possible: API synthetic scheme → scale-up → impurity profile and standards → analytical methods → finished dosage form development → preparation of industrial transfer → regulatory support.

GxP News: How important is the regulatory component already at the R&D stage? Sometimes registration is perceived as a task to be dealt with after development is complete.

Andrey Berman: I consider that approach outdated. Today a regulatory strategy needs to be shaped practically in parallel with the scientific and technological one. Decisions made at the stage of developing the substance and the finished form directly determine the quality of the future registration package.

Therefore at NCSS we strive to build the project from the end goal. The company is developing regulatory practice and consulting and offers project support on issues of development, quality, registration and circulation of medicines. Regulatory process support is also explicitly included in the R&D model.

I would use the term “end-to-end regulatory readiness” here: we try to take into account the requirements for the future dossier not after R&D is finished, but as development proceeds.

GxP News: In that case, can one speak of a “one-stop shop” format for pharmaceutical development?

Andrey Berman: In essence, that is exactly what we are aiming for, although I would prefer the term “a single center for managing development.” The point is not to mechanically gather the maximum number of services under one brand. The main thing is to ensure the coherence of decisions.

In the NCSS R&D center model, alongside the scientific part, economic project assessment, selection of suppliers of the necessary materials, and support of regulatory processes are provided for.

GxP News: In 2026 the state is further strengthening the focus on strategically important medicines and the depth of localization. How much will this change demand for such R&D competencies?

Andrey Berman: In my view, very substantially. In April 2026 the Government approved a new list of strategically important medicines, and in July it was supplemented with another 149 items. This shows how systemic the task of ensuring technological independence for critically important medicines is becoming.

For the market this is a very important signal. The economic value of deep localization is increasing.

GxP News: Who today is a potential partner of NCSS for such projects?

Andrey Berman: The circle of partners is quite broad.

These are Russian pharmaceutical manufacturers that need to localize specific products or take an existing localization to a deeper level. These are companies that have a domestic API and the task of creating a high-quality finished dosage form on its basis.

A separate direction is joint projects with scientific organizations. NCSS uses a flexible project model and, when solving complex scientific tasks, can engage specialized organizations, experts and high-tech research infrastructure.

GxP News: How do you see NCSS in a few years?

Andrey Berman: I would like NCSS to be perceived not only as the National Center for Standard Samples in the narrow sense of that definition, but as one of the integrated science and technology platforms of the Russian pharmaceutical industry.

In recent years the company has already substantially expanded its scope of activity: from development and certification of reference materials — to analytical studies, proprietary chromatography solutions, API and finished dosage form development, regulatory support, full-cycle R&D, and logistics support for manufacturers with pharmaceutical substances and materials. In 2026 this was joined by licensed pharmaceutical activity in wholesale trade, storage and transportation of medicines.

But for us expanding the number of services is not an end in itself. Our task is to connect these directions around one industry need: how to turn a scientific idea or a Russian API into an industrial medicinal product faster, more reliably and with lower technological risk.

GxP News: And a final question. How would you formulate the main thesis of the new stage for Russian pharma?

Andrey Berman: Probably like this: technological independence must become the foundation of technological competitiveness.

The first stage is to learn not to depend critically on an external source of technology. The second is to make Russian technology efficient, reproducible and economically viable. The third is to learn to scale it and enter external markets with a Russian product.

And if the next stage allows Russian developments not only to meet domestic needs but also to succeed in the markets of other countries, that will already be an indicator not of import substitution, but of the industry’s full competitiveness.

Source: industry portal GxP News. Original article — gxpnews.net.