Russia grants Hermes GMP certification at German and Austrian plants

By Dan Stanton

- Last updated on GMT


Related tags Russia

Hermes Pharma has received authorisation to make drugs for the Russian market from facilities in Austria and Germany.

Contract development and manufacturing organisation (CDMO) Hermes Pharma received GMP certification from Russian regulators at its facilities in Wolfsberg, Austria, and Wolfratshausen, Germany.

The accreditation means the firm can offer Russian pharma firms and international firms looking to market products in Russia production of a number of dosage forms, including orally disintegrating granules, lozenges, effervescent and chewable tablets.

“We are currently working with international companies who distribute their products in the Russian market. But of course we are open and interested in partnering with Russian pharma companies interested in launching user-friendly dosage forms in their country,” ​Hermes told us.

“Strategically speaking, we believe that Russia is an interesting and growing market and with the successful completion of these audits we would like to emphasize our commitment to the Russian pharmaceutical market.”

Protectionism vs demand

Since 2011, Russian policy has favoured local production in efforts to reduce reliance on pharmaceutical imports. Vladimir Putin’s ‘Pharma 2020’ policy pushes for as much 90%​ of drugs consumed in Russia to be made domestically by 2020.

Such policies have led multinationals to tap the market through collaborations with domestic drugmakers. Pfizer, for example, teamed with Russian pharma firm NovaMedica last May​​ to build an aseptic manufacturing plant in. But increasingly foreign CMOs like Hermes are being approved to make products for the region due to increasing demand for pharmaceuticals.

Slovakian CMO Saneca Pharma told this publication in December​ that under new requirements foreign facilities can make products for the Russian market so long as Russian regulators audit them once every three years, as well as whenever a customer makes a new product filing in Russia. Saneca received GMP approval from Russian regulators in May 2017 at its facility in Hlohovec, Slovakia.

With such regulations superseding strict protectionist policies, Hermes told us it has no plans to expand into Russia directly.

“As we currently mainly act as a CDMO which means we develop and manufacture for other pharma and healthcare companies and do not import any own brands, we do not see the need to invest in Russia at the moment but this may change in the future.”

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