Terapia – a SUN PHARMA company
- Terapia - a SUN PHARMA company is the largest local generics & OTC company and one of the six largest pharmaceutical companies in Romania. Established in 1921, Terapia has a strong brand name and a consistent track record of growth and profitability.
- The commercial name of the company became Terapia - a SUN PHARMA company in March 2015, after Sun Pharma successfully completed the acquisition of Ranbaxy Laboratories Limited..
- For Terapia, as the leading company in the Romanian generic drugs market, the functions of the Clinical Pharmacology and Pharmacokinetics Unit are essential. The importance of clinical trials, which are essential for demonstrating the efficacy and safety of pharmaceutical products, is also underlined by the evolution of activities and investments performed by the company in this field.
Clinical Pharmacology and Pharmacokinetics Department
- Terapia's Clinical Pharmacology and Pharmacokinetics Department was established in 2002, as the first Centre for Bioequivalence Clinical Trials owned by a Romanian pharmaceutical company;
- Only one year after, our National Medicines Agency granted GLP (Good Laboratory Practice) certification to the center, thus making a landmark in the Romanian pharmaceutical industry;
- Since its beginning, the primary mission of the department has been to serve as a resource center dedicated towards conducting bioequivalence/ bioavailability clinical trials, as per international regulatory standards. By setting up this center, our company has proven once more its status as an innovator and pioneer in the key domains of pharmaceutical research in Romania;
- In June 2005, all the facilities were renovated. Since June 2008, the Clinical Unit benefits from a facility with 48 beds designed to conduct bioequivalence studies and 8 beds designed for Phase I trials (first administration of a medicine to humans) along with a generous, modern space for volunteers and specialized personnel;
- In the last years, a big part of the company’s investments have been oriented towards equipment, modernization and extension of the bioequivalence facilities;
- In 2012, the Centre for Bioequivalence Clinical Trials became the Clinical Pharmacology and Pharmacokinetics Unit;
- At present, Terapia's Clinical Pharmacology and Pharmacokinetics Unit performs the necessary studies for generic products developed in India and destined to reach different pharmaceutical markets from EU, Brazil, Australia and US;
- The department is structured in two distinct units: the Clinical Unit and the Bioanalytical Laboratory;
- Also, the department has in its structure a Pharmacokinetics and Reports group and a Study Quality Control group;
- All Department’s activities are performed by highly specialized personnel, in accordance with Principles and Rules of Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).
Visit the virtual tour for a full presentation of our facilities.