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19 January 2018

NovaMedica Pharmaceutical Plant, Kaluga

In May 2017, Russian pharmaceutical company NovaMedica began building a pharmaceutical manufacturing plant for sterile injectable drugs at the Vorsino Industrial Park, Kaluga, Russia.
NovaMedica announced the construction of a pharmaceutical plant in Kaluga in 2017. Credit: Agency for Innovation Development.
The plant is expected to begin full-scale production by 2023. Credit: NovaMedica.
The Kaluga facility will be used for producing sterile injectable drugs. Credit: Johannes Jansson.

In May 2017, Russian pharmaceutical company NovaMedica began building a pharmaceutical manufacturing plant for sterile injectable drugs at the Vorsino Industrial Park, Kaluga, Russia.

A joint venture of RUSNANO and Domain Associates, NovaMedica is building the plant under a strategic partnership agreement signed with Pfizer in July 2016 that allows it to localise foreign pharmaceutical innovations in Russia.

In March 2018, NovaMedica signed a special investment contract (SPIC) with the Ministry of Industry and Trade of the Russian Federation and the Kaluga Region. The investor will be responsible for developing the project, while the government will provide stable regulations and incentives.

The SPIC will allow NovaMedica to invest more than RUR3bn ($41.7m) in the project and create 300 high-tech jobs, as well as exporting around 20% of the products manufactured at the plant to global markets.

The plant’s construction is expected to be completed in 2020, with full-scale production scheduled to begin in 2023.

Construction of the NovaMedica plant

In 2016, NovaMedica revealed its plans to establish the manufacturing plant in the Kaluga region. The project involves creating isolated production units for manufacturing standard and cytostatic drugs.

“The plant is designed to produce more than 38.5 million cartridge and vial units a year.”

The plant will produce 30 Pfizer-owned pharmaceuticals in the form of sterile injections for the local market. The products will comply with the good manufacturing practice (GMP) standards set out by Russia, Europe and Asia, as well as the US Food and Drug Administration (FDA).

The engineering work was finished by the first half of 2017, while the manufacturing complex is currently under construction.

Design of the NovaMedica plant in Kaluga

The plant is designed to produce more than 38.5 million cartridge and vial units a year. It will occupy a 23,00m² area, including sites for the preparation of sterile injections, lyophilisation and solutions in vials and cartridges.

The plant’s manufacturing lines will be equipped with production amenities similar to those used by major European manufacturing companies, including Optima, Bosch and Mediseal.

Products manufactured at the plant

Pfizer products to be manufactured at the plant include drugs for the treatment of critical bacterial and fungal infections, as well as therapeutics indicated for treating cardiovascular, inflammatory and cancer-related diseases among other therapy areas.

Contractors involved in the project

Germany-based engineering company M+W Group was chosen as the architect for the pharmaceutical plant.

Marketing commentary on NovaMedica

NovaMedica was established in 2012 by Russian venture capital firm RUSNANO and US venture capital firm Domain Associates.

NovaMedica’s research and development (R&D) department plans to develop 15 innovative drugs by 2022 for the treatment of neurological, ophthalmological and gastroenterological diseases.

The company is anticipated to further expand the production of injectable products such as pre-filled syringes and disposable infusion bags based on the requirement and high demand for these products in the region.

From 2018 to 2023, estimated investments in NovaMedica projects by its shareholders and foreign investors are expected to come to more than $200m.

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