Dem Pharmaceuticals Turkey's mission to be one of the fastest growing pharmaceutical companies since 2016 continues to pursue the installation of production facilities. The production facility was established on the basis of the strategy of producing (localizing) innovative products in our country and marketing them to the whole world.
DEM İLAÇ üretim tesisi Yalova İli Çiftlikköy İlçesi’nde It is established on an area of 30 000 m² and has 17 500 m² net indoor area monitored by validated BMS (Building Management System) and EMS (Environmetal Management System) systems. Plant, Republic of Turkey Ministry of Health as well as the Regulation on Medicinal Products for Human Workshop has been designed on the basis of international norms. All the equipment, equipment and infrastructure were procured from international experienced companies, and all the infrastructure is in compliance with FDA, 21-CFR Part XI registration system. Installation, commissioning, qualification and validations have been completed in the production facility which is planned to be operational in September 2020.
The pharmaceutical manufacturing facility consists of separate and isolated sections, which are designed according to the current GMP (Good Manufacturing Practice) rules for FULLY STERILE drugs. In addition, these sections are also isolated in terms of infrastructure in order to completely separate them from each other.
Biotechnological Active Substances Production Department:
- Seed Cell culture: 1L, 5L, 25L and 50L bioreactor systems
- Up-stream processes: Disposable bioreactor systems with 1000 L volume
- Downstream processes:
Ultra and Nano filtration systems
Viral inaktivasyon ve virüs filtrasyonu
Nanotechnological Active Substances Production Department:
Nanoparticular active substance production
Sterile Preparation Production Departments:
Vial Filling Line
Bulb Filling Line
Ready Injector (PFS) Filling Line
Lyophilized Pharmaceutical Production Line
Finished Product The capacities of the production lines are given below:
27.000.000 Flakon /yıl (2ml, 3ml, 5ml, 10ml, 30ml’lik flakon doldurma kapasiteli)
60.000.000 Ampoules / year (2ml, 5ml, 10ml ampoule filling capacity)
36,000,000 PFS / year (1ml, 2ml ampoule filling capacity).
In addition to the production facility, 1800m equipped with high technology devices, designed in accordance with the current EU-GLP (Good Laboratory Practices) principles2 All analyzes of raw materials, packaging materials, semi-finished and finished products can be made in Quality Control Laboratories.
2000 m2 closed warehouse areas are managed in accordance with current Good Manufacturing Practices and Good Distribution Practices principles.
Dem Pharmaceuticals continues to work to localize the production of new, innovative products with advanced technology.