Polipharma Industries is a GMP-certified drug manufacturer established in 2003, whose core business is the manufacturing of pharmaceutical products. We provide activities and services such as: research & development, out-licensing, contract manufacturing, contract development, batch release, analytical services and clinical trials.
Headquartered in Sibiu, the centre of Romania, Polipharma Industries competes in the global market by selling quality products in over 20 countries.
Polipharma’s generic products are under registration / marketed in Europe, the Middle East, Asia and North Africa.
Polipharma Industries currently manufactures a wide range of products in different pharmaceutical forms. These forms include: tablets, coated tablets, capsules, ready to use solutions, freeze-dried solutions and prefilled syringes. Different therapeutic areas include: cardiology, central nervous system, diabetes, anticoagulation and oncology.
Its current food supplement portfolio includes: vitamins and minerals, products for the digestive system, liver protection, the immune system, memory improvement, sleep disorders and anxiety, weight loss and weight control, urinary tract protection, blood circulation, eye health, free radicals neutralisation, prevention of motion sickness, diabetes prevention and control, joint mobility, brain and liver health.
Food supplements for children
Polipharma’s OTC portfolio includes: NSAIDs (ibuprofen, aspirin), analgesics and antipyretics (paracetamol), platelet aggregation inhibitors (aspirin), antispasmodics (drotaverin).
Polipharma Industries has two modern R&D centres: one for non antibiotics oral solid dosage forms and another one for oncology products, both solid and injectables; and four manufacturing sites for: non-antibiotics oral solid dosage forms, oncological oral solid dosage forms, oncological injectables pilot plant and oncological injectables industrial plant.
The Bioequivalence Centre, established in 2013, has been fully equipped to meet the demand for clinical trials and research. The bioequivalence team supports protocol development up to the completion of the clinical trial report for regulatory submissions. We have a competent team and the staff is trained to conduct the clinical studies. The bioanalytical testing methods are rigorously developed and validated before they are used in sample analysis.
Polipharma’s Bioequivalence Centre has a fully integrated organisational structure, comprising a clinical unit, a bioanalytical laboratory and pK and statistical specialists.
The clinical unit is fully equipped, with a capacity of 26 beds. It is an independent clinical unit with highly trained and experienced clinical investigators, ensuring that your bioequivalence clinical studies are conducted in a well-controlled environment on healthy human subjects.
A state-of-the-art bioanalytical facility and the expertise of the analytical staff make possible the development and validation of bioanalytical methods, as well as the analysis of biological samples coming from your bioequivalence clinical trials.
Polipharma Industries provides services such as: contract manufacturing, contract development, analytical services, out-licensing, batch release and regulatory. It has special expertise in handling high-potency formulations, including cytotoxic APIs. Also, Polipharma Industries conducts in-house development projects and other development cooperations with partners in core technologies.
Founded in 2003, Polipharma Industries has evolved as a leading pharmaceutical company with steadfast reputation for quality. Having more than 300 employees, its goal is and always will be to research, develop, manufacture and deliver quality affordable therapies to everyone around the world. Our portfolio development criteria are: innovation – development of new pharmaceutical formulations, diversity – covering important therapeutic areas, and addressability – products for all patient categories.
Polipharma Industries is committed to maintaining the highest quality standards and current good manufacturing practises. Polipharma Industries invests in quality. Its integrity and transparency have attracted global investors who believe in Polipharma Industries’ performance, commitment and potential. Polipharma Industries accelerated its speed to market and expanded the geographic footprint to become faster and more competitive. It is always challenging itself to get better.
Over the last 10 years, Polipharma Industries has invested more than €50 million in the plant, in specialists, and in processes and equipment that meet the state-of-the-art production capabilities in compliance with the European GMP standards.
Polipharma Industries strives to continually improve and become stronger. With high-speed and high-volume filling capacities with automatic inspection, labelling and packaging processes we have the necessary resources to support you with efficient services of high quality. Polipharma Industries is an attractive partner for the small, medium-sized and big pharmaceutical companies.