Romania

According to the most recent CEGEDIM report, Terapia – a SUN PHARMA company is the number one Romanian generic company and ranks among the six biggest players in the local pharmaceutical industry.

The Clinical Unit of the Clinical Pharmacology and Pharmacokinetics Department received a new permit from the Ministry of Health regarding the development of Phase I clinical trials for human use medicines. The new certificate is valid until 2018

The National Medicines Agency (ANMDM) grants a new Good Laboratory Practice (GLP) Certificate to our Bioanalytical Laboratory within the Clinical Pharmacology and Pharmacokinetics Department. The ANMDM inspection was carried out within the procedural two years’ time frame and ended-up with the release of the authorization for another two years.

In March 2015, Sun Pharma has announced the successfully completion of the formal merger with Ranbaxy, thus becoming the 5th largest specialty generics company in the world and the No.1 pharma Company in India, with ground presence in 65 nations and products sold in over 150 nations

The key objective of this merger was to capture the full value of the substantial synergies and to create opportunities for all stakeholders, while accelerating the development of a solid and extensive product portfolio to the benefit of worldwide patients;

As a natural consequence of the merger between Ranbaxy and Sun Pharma, the commercial name of the largest Romanian generics & OTC company will now be “Terapia – a SUN PHARMA company”.

Inauguration of the construction site for the future Terapia Ranbaxy R&D facility, at Cluj. The new center will be co-financed from European funds and will feature three new laboratories: one for research and development of new generic products, one for research, development and optimization of manufacturing processes and an analytical development laboratory.

Accomplished the decontamination project of the site for Soil & Ground Water and obtained the Environment Authorization for next 10 years

The Bioequivalence/ Bioavailability Department is authorized by the Brazilian Health Surveillance Agency (ANVISA) to conduct bioequivalence studies which will support registration dossiers for Ranbaxy generic products designed for the Brazilian market

The U.S. Food and Drug Agency (FDA) and the National Medicines Agency inspect the Bioequivalence/ Bioavailability Department; no deficiencies are found in our activity.

The Clinical Unit within the Bioequivalence/ Bioavailability Department receives from the Ministry of Health the first permit to carry out Phase I clinical trials for human use medicines (renewed on a regular basis)

By launching the osteoporosis medication Evista® in Romania, Daiichi Sankyo and Ranbaxy are leveraging synergies generated through the Hybrid Business Model for the first time in Europe.

Daiichi Sankyo Company, Limited one of the largest pharmaceutical companies in Japan, acquires the majority of the voting capital of Ranbaxy;

Ranbaxy remains the main shareholder of Terapia Ranbaxy.

Ranbaxy Laboratories Ltd. announces the completion of the acquisition process by Ranbaxy Netherlands BV of 96.7% of the top Romanian generics company Terapia S.A.

Through the combined operations of Terapia and Ranbaxy in Romania, the commercial name of the new entity became Terapia Ranbaxy;

The legal name of the company remains Terapia S.A.

The company is delisted from Bucharest Stock Exchange.

The company is acquired by a consortium led by Advent International;

The National Medicines Agency grants GLP (Good Laboratory Practice) certification to our Centre for Bioequivalence Clinical Trials, thus making a landmark in the Romanian pharmaceutical industry.

Launching the first Centre for Bioequivalence Clinical Trials owned by a Romanian pharmaceutical manufacturer.

Terapia becomes the first Romanian company to receive a Good Manufacturing Practice (GMP) Certificate from the National Medicines Agency

Listed at the Bucharest Stock Exchange

The company became private through the mass privatization process, shares being controlled by institutional and individual holders.

The company became a company of shareholders, SC TERAPIA SA, all the plant and equipment as well as the intellectual property and brands being at that time in the possession of the State.

Terapia portfolio includes 200 chemical-pharmaceutical compounds and medicines for human use: medicines for treatment of cardiovascular, digestive, allergic, rheumatic disorders, anesthetics, opioids etc

The company launched the first section for organic synthesis in Romania: Cloramfenicol section. This was the only one antibiotic made exclusively through chemical organic synthesis; at that time, few countries in the world were able to produce it.

The first logo of the company was registered at OSIM (Romanian State Office for Inventions and Trade Marks) under the name „General logo T”. The graphic representation is the contour of an autoclave in cross section having inside the character T (from Terapia).

First export of pharmaceutical products is now registered

The chemical-pharmaceutical laboratory “TERAPIA” was established at Cluj by Professor Dr. Reinbold Adalbert and Dr. Wilhelm Stern.