Krka opens a new plant for the production of active pharmaceutical ingredients in Krško

Vertical integration: managing the process from the raw material to the finished product

The new Sinteza 1 plant in Krško is an important acquisition for Krka. This investment allows Krka to further strengthen its vertically integrated business model, giving the company a key strategic advantage in managing the development and production of products from the API to the finished product.

The Sinteza 1 plant will guarantee an optimal production of strategically important APIs, increasing the competitiveness of Krka’s products and consolidating the company’s position in the market. Vertically integrated products are the result of Krka’s own development and know-how, representing more than 70% of Krka’s portfolio.

Krka’s own production on most of its key API’s enables the company to plan and manage the entire vertically integrated business process, which results in high quality, effective and safe APIs. This allows Krka to be the first to launch its generic products to the select key markets and have the necessary speed and flexibility to react to regulatory and market changes, as well as better handle business risks.

A modern plant with a surface area of 5,529 m²

Construction began in July 2012. Production in the plant’s first module began in the summer of 2014; this summer, the plant’s second module became operational as well.

The plant provides additional flexibility to the production process, since the production of new products can be established in a relatively short period of time. The plant enables small batch production of APIs and intermediates, but large batch production can also be established there if necessary; there are 32 reactors, 6 centrifuges, 2 filter driers and 6 vacuum driers.

The production process is carried out in line with the Good Manufacturing Practice and under controlled conditions in line with the European Directive REACH. A computer system is used to carefully monitor and manage the entire process.

Infrastructure and auxiliary facilities with support systems for providing electricity to the production as well as office and laboratory spaces are located next to the production plant; the plant also has its own water supply and two steam boilers supply the necessary energy. There are 61 people working at the plant; half of them work in production, the other half in the technical service.

Personnel safety and environmental protection

Particular attention was given to personnel safety and environmental protection when designing the Sinteza 1 plant, with all the technical solutions being subjected to these two principles. The plant has been certified and operates in line with the standards ISO 14001 Environmental Management and ISO 18001 Health and Safety Management.

Production is carried out in closed systems. Contaminated air is purified with a state-of-the-art thermal oxidation of waste gases. Waste is timely handed over to authorised contractors, and waste water is disposed into the public sewage system that ends in a central waste treatment plant. The plant is protected with a modern detection and fire alarm system with active fire protection.

Strategic location for the production of APIs

The new plant was built due to the spatial restraints imposed by the central location in Novo mesto. In Krško the company found the right plot of land and infrastructure, which met the requirements of pharmaceutical production.

The plot of land covers 16.6 hectares and will be a strategic location for building new plants for chemical production in the future as well. To meet the needs of raw material supply, the company will build new plants for producing APIs. The new location has several advantages: relative proximity to the parent company and the motorway network, which facilitates communication between systems.

In the last decade, the Krka Group has allocated EUR 1.2 billion to investment projects, of which EUR 174 million was allocated in 2014 and EUR 165 million in 2015. There are approximately 20 Krka Group investments projects currently underway, all of which will help increase the company’s production capabilities in the next few years by more than one third. This will boost the annual production output from nearly 13 billion tablets and capsules to more than 17 billion.