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“The Hardest Period is Over…”

Irina BRAGINSKAYA, General Director JSC Berlin-Pharma

After three years of JSC Berlin-Pharma’s operation, what specifics have you noted on the Russian market? What contributes to the company’s development and what, if anything, hinders it?

Berlin-Pharma’s plant at the Grabtsevo industrial park is the first facility established by the Berlin Chemie/Menarini international group in Russia. Today, it is a high-tech complex for manufacturing, control and storage of pharmaceutical drugs. The company complies with GMP safety standards and has the capacity to annually manufacture 47 million packages of medication used in cardiology, neurology, gastroenterology and other fields of medicine.

In the three years of its operation, Berlin-Pharma has been consistently and reliably manufacturing pharmaceutical products that are supplied to the Russian market. We have so far registered 8 products, with 8 more undergoing registration with the Russian Ministry of Healthcare. What contributes to our development is the planning and support Berlin-Chemie/Menarini’s efforts to localize manufacturing in Russia.There is a lot of support from the administration of Kaluga Region, agencies for regional and innovation development on all stages of implementation of our investment project, with precise compliance with contractual obligations on their part.

As for hindering factors – I guess “hinder” is not exactly the right word, but what prevents us from developing faster is the very lengthy registration procedure – around 2 years for one product. Naturally, we launch parallel projects. Last year, we obtained several registration certificates for full-cycle production.

What key products does Berlin-Pharma currently manufacture for the Russian market? Are you planning to expand the product portfolio or increase production volumes?

Berlin-Chemie/Menarini products are well-known in Russia. They have long earned the trust of healthcare specialists and patients. The company has already registered more than 100 pharmaceutical drugs in Russia, in over 10 therapeutic categories. The concern is always quick to react to Russian market demands and is invariably among the top three major manufacturers of pharmaceuticals that are of continuous demand in Russia. The Russian pharmaceutical market is extremely attractive. We carefully monitor all trends in the pharmaceutical industry and strictly comply with the Russian government’s policy in the field of supply of Russian citizens with high-quality and affordable medicinal products. I am confident that Kaluga’s pharmaceutical cluster will be moving towards maximum substitution of imports and localization of pharmaceutical drug manufacturing.

Our main products lines today are Mezim Forte, Curantil and Prostamol Uno. We are planning to launch manufacturing of Siofors (3 products) that are intended for treatment of 2 type diabetes, and are preparing for registration of the widely-known Bromhexine Berlin-Chemie.

We are planning to increase production volume, primarily, by expanding the product range, but also by expanding the market. Thus, we are considering the possibilities for exporting products to countries of the Eurasian Economic Union.

What were the company’s results for 2016 and what are its plans for this year?

In 2016, Berlin-Pharma manufactured and sold more than 28 million packages of finished pharmaceutical drugs. This was done in a single-shift mode, i.e. far from our full production capacity.

The hardest period is over: when the plant was already built and equipment installed, but it could not begin production due to lengthy procedures for production licensing and registration of pharmaceutical products. We are now working with stability, and in 2.5 years have overcome the start-up period (inevitable for all new plants) when our costs were higher than our revenues and managed to cover losses for 2013-2014.

Berlin-Pharma has a cooperation project with Merz. What is the nature of this project? How is it developing?

It is too early to speak about the project. I can only say that 3 innovation products that will be manufactured in Kaluga are currently on the registration stage.

Are there any partnership collaborations within the cluster? How do you think such cooperation should develop?

So far, partnerships mostly relate to organizational issues.

But there is practical assistance as well – in the form of resource training. We are currently considering collaboration in manufacturing as well. We were approached by an Obninskbased Russian company regarding packaging of their pills in aluminum blisters. We have the technical capability to do that and can help. However, such a project can only be implemented after appropriate registration with the Russian Ministry of Healthcare, so it’s a long-term prospect.

I would say that at this point we are operating rather autonomously, but I do not exclude partnerships of any format. At least we, on our part, are prepared for them.

 

COMPANY DETAILS

JSC Berlin-Pharma is part of Menarini Group – a major European pharmaceutical conglomerate. The group operates 9 pharmaceutical plants in different countries.

Berlin-Chemie AG joined the group in 1992.

Strategic goals of the consolidated Berlin-Chemie AG/A.Menarini are innovative research and internationalization of the healthcare market. The group has an impressive portfolio of products developed by its own resources and a high potential for establishment of reliable partnerships with other pharmaceutical companies.

In 2010, Berlin-Chemie AG/A.Menarini began the implementation of a major investment project to build a pharmaceutical plant in Kaluga Region. The project includes a plant for full-cycle production of non-sterile dosage forms, and office, laboratory and warehouse complex. The total amount of investments exceeds 40 million euro.

 

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