DEVARGE

DEVARGE continues its activities with the vision of becoming the top generic drug manufacturer of Turkey. It mainly develops products exportable to international markets and high quality affordable products. 

With our strong staff of 153 trained personnel who are experts in their fields and fully fledged laboratories and manufacturing sites equipped with cutting-edge technology , we aim to develop new forms with high added value and innovative products. 

On the other hand, we work to perform R&D activities in compliance with all ethical and legal principles in a manner to meet the expectations of the concerned authorities; prove that the safety, efficacy and quality of the products do not change throughout the shelf life , increase product accessibility, develop sustainable methods to increase efficiency and adapt production to new technologies. 

The operating principle requires product quality meeting current standards, and finding new formulations, new dosage forms, and different routes of synthesis and/or new polymorph methods that do not infringe patents for raw materials. 

Our long-term goal is to become a pioneer in developing generic drugs, ensure vertical integration in strategic products, compete with the world in developing active ingredients and new polymorphs, create a difference by developing products with added value, to continue to develop products for regulated markets (EMA and FDA), invest in our future by adapting new technologies to our company, develop products with high value by means of cooperation between universities and the industry, and ensure protection of our rights by patent registration. 

DEVARGE comprises of Analytical Development, Pharmaceutical Development, Pharmaceutical Technology, API Development, CMC Documentation, Patent and Biotechnology units. 

DEVARGE contains Pre-formulation and Pilot Manufacturing Area, Synthesis and Scale-Up Laboratories, Stability Area, Analytical Development Laboratories, Biotechnology Laboratories, Oncolytic and Hormone Manufacturing Area, Pilot Manufacture Weighing Area, Raw Materials, Packaging Materials and Finished Products Storage Areas, and CMC Documentation archives, covering a total area of 7,000 m2. 

The bioequivalence studies of 28 products which is an indicator of equivalence of the product to the innovator product were completed and it was determined that the products obtained by the unit formula and the manufacturing method developed were identical with the reference product in terms of efficacy and safety. As of the end of 2015, the development projects and the CTD file preparations of 56 new products have been completed. 

In 2015, technology transfer studies were performed for 10 products, gaining new technologies to our country. Alternative raw material resources studies were performed for 32 products, resulting in a decrease in costs. 

ANDA registration application files were prepared for 5 products to be submitted to FDA, the US Health Authority. Applications were submitted to EMA, the European Union Medical Agency, for 2 products. The development studies for two new active pharmaceutical ingredients (APIs) were completed in 2015. Validation charges were produced for the two APIs developed by our company. 

The Drug Master Files (DMFs) for the two active pharmaceutical ingredients developed were prepared in the CDT format. 

Three articles written by compiling the results of the API R&D studies were published in an international journal (Journal of Pharmaceutical and Biomedical Analysis). 

The impurities were synthesized for some APIs we currently manufacture and commercially sold. In 2015, 6 patent applications were submitted, 2 of which were APIs and 4 of which were finished products. 

In 2015, application for support was submitted to TÜBİTAK for a total of 5 innovative projects. 

Within the scope of the cooperation between universities and the industry, joint studies have been being conducted with several universities. 

DEVA was chosen as the best site of the year by the Ministry of Science, Industry and Technology in 2015, and two times deemed worthy of the Golden Mortar Award granted by Eczacılık journal.