Pharmstandard is celebrating its 20th anniversary this year. Dmitry Zaitsev, Pharmstandard JSC CEO, told Regnum News Agency in an interview about what has already been done over the past years and what projects are in prospect.

In August, the IX All-Russian GMP Conference, which involved international participation, was held in Ufa. The conference, in particular, focused on continuously developing the production of efficient, quality, and safe medicines, expanding international dialogue, and improving regulatory systems. The event’s general partner was Pharmstandard, one of the leaders of the Russian pharmaceutical market. Pharmstandard is celebrating its 20th anniversary this year. Dmitry Zaitsev, Pharmstandard JSC CEO, told Regnum News Agency in an interview about what has already been done over the past years and what projects are in prospect.

Dmitry, the IX All-Russian GMP Conference was hosted in Ufa this year. It is also home to one of the oldest pharmaceutical companies in our country, Pharmstandard-UfaVITA. How did it become possible for an enterprise with a rich history to become a high-tech pharmaceutical complex and one of the largest pharmaceutical manufacturers in our country?

“Such dualism in the combination of historical experience and innovative technologies is possible due to continuous development, the basis of which is large-scale investments, growth of competencies, and support of the industry by the government, including federal programmes and national projects.

Today, Pharmstandard Group includes five pharmaceutical plants and manufactures medical devices and equipment. Our primary drug production sites in Russia are located in Ufa (Pharmstandard-UfaVITA JSC), Kursk (Phs-Leksredstva JSC), Tomsk (PHS-Tomskhimpharm JSC), and the Vladimir region (LEKKO CJSC). Also, together with our partner, OTCPharm, we are involved in developing a pharmaceutical facility for producing solid dosage forms, OTCPharm PRO, in Kaliningrad. The production was launched in 2023. 

Since 2022, Pharmstandard has owned a 70 percent stake in the authorised capital of Daliompharma. This company, located in Nesvizh, Republic of Belarus, produces medicines and pharmaceutical substances derived from human blood plasma.

Developing blood product production is one of our company’s strategic directions. In Ufa, we are already producing blood coagulation factor VIII. Another important project in this area will be implemented within the Alabushevo Special Economic Zone.”

Please tell us more about the current status of the blood coagulation factor VIII production project.

“It should be noted that the project is of great social importance, as it is the first mass or large-scale production of blood coagulation factor VIII in lyophilized form in Russia. The drug is crucial for patients with haemophilia A.

We started the project in 2019. Since then, we have conducted an international multicentre clinical trial and built and commissioned a new state-of-the-art production facility with an area of more than 1,550 square meters and the latest technology. Total investments in construction and equipment amounted to over RUB 1.6 billion.

This year, we reached full capacity and started supplying the drug to patients in the Russian Federation. The enterprise is capable of producing up to 370 million IU/year. Before that, the country’s needs were met only by foreign producers.”

The investment plan announced by Pharmstandard for the next three years is worth 25 billion roubles. What kind of projects are we talking about?

“Any development is impossible without investment. Over the last three years alone, we have invested more than RUB 12.5 billion in production facilities and R&D. What, in particular, were these funds used for? In Ufa, the production of drugs in polymer dropper vials and plastic ampoules using the BFS technology (“blow-fill-seal”) was launched. It is a specialised technology for packaging drugs under aseptic conditions. We use this technology to produce, for example, ophthalmics.

At our Kursk plant, we have built a large-capacity production facility for solid dosage forms, producing analgesics, drugs for treating ENT disorders, and a line of cardiac medications. This year, a unit for producing soft gelatin capsules was launched in Kursk, where non-steroidal anti-inflammatory drugs and vitamins will be made.

For the next three years, the investment plan is twice as big. In June this year, at the St. Petersburg International Economic Forum, we signed an agreement with Moscow Mayor Sergey Sobyanin to construct a plant for processing human blood plasma in the Alabushevo Special Economic Zone. The planned processing capacity is 600 tons of human blood plasma per year, with a future capacity of up to 900 tons per year. This is a strategically important facility. The plant will produce products in demand in our country, such as albumin and normal human immunoglobulin. 

In Ufa, we continue to construct a new production and warehouse building with a total area of more than 25,000 square meters. This building will house administrative and auxiliary divisions and production sites. In particular, the expansion of the production of lyophilized products and eye drops and the launch of a new production of suppositories are planned.

While building up our competencies, we also absorb international experience. For example, together with Pfizer, we are implementing projects in Ufa to produce finished dosage forms of four partner oncology drugs for the treatment of kidney cancer, breast cancer, lung cancer, and chronic myelogenous leukaemia. Many other international pharmaceutical companies remain among our partners.

We hope that the existing production facilities and large-scale investment projects will further strengthen our country’s drug security. The growing demand of our citizens for high-quality Russian-made drugs is the main driving factor for our further development.”

Reference:

Pharmstandard CEO talks about large-scale production expansion (regnum.ru)