Russian pharmaceutical map has a new point of convergence

23 October 2017

GMP News

An interesting international pharmaceutical project has started in Russia. This project is a result of a convergence of interests of Rusnano, Russian state investment corporation, Domain Associates, an American venture capital foundation, and Pfizer, an American pharmaceutical corporation.  

May 30, 2017 NovaMedica, pharmaceutical company established in 2012 by Rusnano JSC and Domain foundation, announced start of construction of the plant for sterile injectable manufacturing. Key partner and investor for this project is Pfizer – global pharmaceutical giant intends to localize about 30 EDL products at NovaMedica manufacturing site. Proprietary R&D products of NovaMedica will be manufactured at this plant as well. Moreover, there is a possibility to attract to the project other potential partners in order to localize complex injectable dosage forms.  

The plant will be constructed in the Industrial Park Vorsino in the Kaluga region which was recognized as the most attractive region for investors in Russia. The to-be-constructed plant will become the part of the Kaluga pharmaceutical cluster – the most powerful in the number of pharmaceutical production facilities and their manufacturing capacities in Russia. It includes facilities, which localize products for Big Pharma to serve the growing Russian market, such as AstaZeneca, Berlin-Chemie, NovoNordisk, Stada. NovaMedica plant will meet requirements of not only Russian, but also European and Eurasian Good Manufacturing Practice (GMP) for medical products which, together with world-class capabilities should bring high-quality products to Russian market.

The launch of construction works was  announced by Anatoly Chubais, the Chairman of the Management Board of Rusnano, Anatoly Artamonov, Governor of the Kaluga Region, Sergey Tsyb, Deputy Minister of the Ministry of Industry and Trade, Petra Danielsohn-Weil, Regional Head Europe Pfizer Essential Health, Leonid Melamed, Chairman of the Board of Directors of RMI Partners, Managing Company of NovaMedica, and others. Symbolic ceremony of construction start was an impressive, spectacular and unusual event. Distinguished guests took hand trowels and added stones into the missing puzzles of a mosaic which was made in the form of NovaMedica logo by local Vorsino craftsmen.

The engineering contractor firm “M+ W Group” creates conceptual design of the plant. “M+ W Group” is one of the global leaders in the market of the design, engineering and construction of high tech facilities and major complex projects. The plant has a projected capacity of more than 38.5 million units per year. The total area covered by production and auxiliary buildings and structures will be about 23,000 square meters. The manufacturing facilities will be equipped with production lines assembled by the leading European manufacturers: Bosch, Ziel, GEA-lyophyl, Bausch+Ströbel, Belimed, Seidenader, Optima, Mediseal, Uhlmann and others.

The production facility will be represented by area for production of sterile injectable forms: lyophilizates and solutions in vials. There is also a possibility of further expansion of production for demanded forms of injectiable products. The facility design includes creation of isolated blocks for production of standard and cytotoxic drugs. Construction of the plant is expected to be completed in 2020. 

Anatoly Artamonov, Governor of the Kaluga Region:

“The pharmaceutical industry of the Kaluga region is the most dynamically developing direction in the regional economy. The cluster of pharmaceuticals, biotechnology and biomedicine, created six years ago, today unites 63 participants, has a “bronze status” of the best European cluster practices, is one of the pilot innovative territorial clusters. Enterprises located here produce more than 140 medicines and pharmaceutical substances. We relate further development with increased competitiveness of these products and expansion of its range. In this sense plans of the NovaMedica company coincide with ours. It is planned to produce those medicines that are not produced yet at the to-be-created production site. We wish the company good speed in implementing of the project. For its part the region is ready to provide partners with the necessary assistance”.

Petra Danielson-Vale, Regional Head Europe Pfizer Essential Health and member of the Board of Directors of NovaMedica»:

“We are pleased with the new stage of our partnership with NovaMedica, which is aimed at providing Russian patients with access to locally produced high-quality vital drugs. It is important to note not only our joint efforts, but also the support we receive from the Kaluga Region Government in the implementation of the project. The upcoming stage is the construction of the modern production complex of NovaMedica, to which Pfizer will transfer production technologies of more than 30 sterile injectable products from the company's portfolio”.

Anatoly Chubais, Chairman of the Executive Board of MC “RUSNANO” and Chairman of the Board of Directors of NovaMedica:

“NovaMedica is rapidly developing: in April 2017 the Technological Center with R&D-laboratories and pilot production was launched, where innovative dosage forms are already being developed. A little more than a month has passed and we are opening a new page – we are launching the construction of the GMP plant in partnership with the giant of the world pharmaceutical industry, Pfizer. Moreover, the work on the creation of this plant is being carried out literally since the signing of the partnership agreement. On the part of Pfizer professionals with the vast experience from different countries of the world joined the project so that the plant was designed flawlessly from all points of view. This joint work has already given the team of NovaMedica invaluable experience, and we obtained confidence that the project will be implemented successfully and with great efficiency”.

Alexander Kuzin, General Director of NovaMedica:

“The start of construction of the plant is an important stage in the consistent strategy of NovaMedica to localize innovative products and technologies in Russia. This project would not be possible without conditions created by the state for the development of our industry. We thank the creators of the “Pharma 2020” program – the Ministry of Industry and Trade, as well as the Ministry of Health and our shareholders: Rusnano and Domain Associates – for the consistent support, which helps to think on the large scale, build ambitious and long-term plans, and confidently implement them. We are grateful to our shareholders for the powerful intellectual contribution and comprehensive support motivating the team of NovaMedica for a breakthrough development. And, of course, we are inspired by the prospect of obtaining a unique experience in the process of working together with the leader of the world pharmaceutical industry, Pfizer”.

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