Russian partnerships: Pfizer and NovaMedica break ground on aseptic plant

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Pfizer and NovaMedica have broken ground on a manufacturing facility in Kaluga set to supply the Russian market with sterile injectable drugs.

The ceremony this week comes five months after global pharma firm Pfizer announced it had completed the transfer of the rights and technologies for the production of over 30 medicines to NovaMedica, a Russian pharmaceutical company it forged a partnership with last year.

The portfolio of high-tech medicinal products that the parties plan to produce at the NovaMedica plant includes essential drugs for the treatment of severe bacterial and fungal infections, inflammatory diseases, cancer, as well as for use in anesthesiology,” a Pfizer spokesperson told in-Pharmatechnologist.

“It’s too early to discuss volumes, but the focus is on the Russian market. The facility will be built in accordance with current global Good Manufacturing Practices standards and requirements of the Russian authorities.”

The site, located in the Vorsino Industrial Park, will use technologies including lyophilization and production of sterile emulsions and is expected to be operational in 2020.

It will be the second Kaluga GMP facility for NovaMedica which constructed an $85m plant in the Grabtsevo technopark in 2013 in a joint venture with the Russian government.

Russian partnerships

Pharma 2020 was launched in 2011 by Vladimir Putin – then Russian Prime Minister – in an effort

to help increase local drug manufacture and reduce reliance on imports by producing 50% of all drugs (and 85% of the medicines it deems essential) by 2020.

Pfizer’s partnership with NovaMedica is the latest example of Big Pharma looking to secure access to a market estimated to be worth over $35bn by 2020.

GSK formed a JV with Binnopharm in 2011, while AstraZenecaNovartis and Novo Nordisk have all invested in Russian production facilities.

“Pfizer has partnered with NovaMedica as we have a shared vision in support of Russia’s Healthcare 2020 to increase the availability of high-quality sterile injectable medicines in Russia and to provide patients with access to a portfolio of difficult-to-manufacture sterile injectable products,” we were told.

“Partnerships are vital for Pfizer to achieve our goal of widening access to medicines for Russia patients, and we have a number of existing partnerships in Russia. When choosing a partner, serious consideration is given to ensure that our high quality standards can be maintained.”

Pfizer also has a partnership with NPO Petrovax Pharm for its pneumococcal vaccine Prevenar 13. The Moscow-based pharma company is officially recognized as the manufacturer of the vaccine, the spokeperson said.

“This project, started in 2011, is a unique example of technology transfer of full-cycle production of innovative vaccines as for Pfizer – there are only four countries in the world where the vaccine is produced, as well as for Russia.”

Meanwhile Pfizer has an agreement with POLYSAN Scientific and Technological Pharmaceutical Company to localise three Pfizer medicines at POLYSAN’s facility located in Saint-Petersburg. Manufacturing of the first commercial batches of the medicines is planned for 2018.

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