Operations and Activities
PLIVA's operations comprise of the production of finished dosage forms and active pharmaceutical ingredients, commercial operations, which are marketing and sales activities in Croatia and Southeast Europe, and research and development of generics and active pharmaceutical ingredients.
The production site in Zagreb specializes in the production of oral solid forms, sterile forms, creams and ointments.
Thanks to the approvals by the US Food and Drug Administration (FDA), the British Medicines and Healthcare Products Regulatory Agency (MHRA), the Croatian Agency for Medicinal Products and Medical Devices (HALMED) and other relevant European agencies, PLIVA is one of the manufacturers complying with the highest global quality standards required for international markets. PLIVA's production site in Zagreb plays a very important role for various Teva's markets, and it is one of the strategic production sites for the entire TEVA Group.
It manufactures mainly tablets, which are delivered to about 40 different markets, the major ones being the US, Russian, Ukrainian and Croatian markets. The projects for the increase of the current capacities of the oral solid forms facility are underway, with the intention of further increasing its production volume.
PLIVA has a long tradition in the production of bulk pharmaceuticals – its active pharmaceutical ingredients and intermediates have been present in the most demanding US and European markets since the mid 1960s.
Active pharmaceutical ingredients manufactured at PLIVA are incorporated in PLIVA's and Teva's drugs. This, in addition to their sale to external customers in international markets, represents our long-term strategy. The development of new and the production of already registered APIs are carried out at two sites - in Zagreb and in Savski Marof. The production complies with strictly defined international standards, and it is regularly audited by a number of foreign regulatory agencies and business partners. The joint inspection carried out by the US Food and Drug Administration (FDA), the British Medicines and Healthcare Products Regulatory Agency (MHRA) and the Croatian Ministry of Health and Social Welfare in 2009 is especially important for PLIVA. Although the FDA has been inspecting PLIVA's production since 1965, this was the first inspection ever, both in Croatia and globally, to be carried out jointly by these three institutions.
Visit the TAPI website www.tapi.com for more information about TAPI and for the complete product list - including information about each product's DMF's and CEP's.
Commercial Operations cover a broad spectrum of activities related to the marketing and sales of medicinal products in the Croatian market. A significant part of medicines manufactured at PLIVA in Zagreb is intended for the Croatian market.
Through many years of successful cooperation PLIVA's medical representatives have built high-quality relationships with the entire professional community, including primary healthcare physicians, specialists, pharmacists and wholesalers and pharmacies. Business excellence is embedded in PLIVA's policies, and special attention is devoted to continuous development of relationships with all stakeholders, and especially those active in the healthcare system - physicians, patients, pharmacists and state institutions.
PLIVA holds the leading position in the Croatian market, both in the Rx and the OTC segments. In 2011, it had almost 200 molecules (more than 290 dosage forms) included in the Reimbursement List of the Croatian Institute for Health Insurance, and it plans to register a number of new products.
In 2010 PLIVA became a member of the Croatian Association of the Self-Medication Industry, founded with the Croatian Employers' Association, and it operates in line with the Association's basic goal, which is the creation of a positive environment furthering the use of non-prescription medicines and self-care products.
The merits for all of PLIVA's achievements to date and its current status may be greatly attributed to the in-house research and development activities which have a 70-year long tradition.
Clearly defined research and project management processes, focus on niche areas, use of state-of-the art technologies and scientific methods, and systematic protection of intellectual property rights are the basic components of PLIVA's research and development strategy.
Currently, PLIVA's R&D strategy focuses on the development of generic medicines, and Zagreb is one of the most important research centres within the Teva Group. The purpose of these development projects is the efficient development of new chemical synthesis processes for generic substances, development of new finished dosage forms, i.e. generic products, over-the-counter products or new entities (i.e. molecules under patent protection) through innovative technologies, development of analytics and organization and performance of clinical studies.