SAP
Tüm satın alma, üretim ve lojistik işlemleri, süreçlerin etkin ve kontrollü şekilde yönetilmesini sağlayan SAP yazılımı ile yürütülmektedir.
MANUFACTURING
Manufacturing Powered by Advanced Technology
With our high-tech manufacturing infrastructure, modern facilities and robust quality standards, we deliver reliable, flexible and sustainable manufacturing across a variety of product forms.
OUR MANUFACTURING CAPACITY
High Capacity, Flexible Manufacturing Capabilities
With our manufacturing infrastructure and high capacity across various sterile product forms, we respond to changing needs quickly and effectively.
With our capabilities in ampoule, liquid vial, lyophilized vial and prefilled syringe manufacturing, we provide a robust and scalable manufacturing structure.
With our capabilities in ampoule, liquid vial, lyophilized vial and prefilled syringe manufacturing, we provide a robust and scalable manufacturing structure.
70
M
Annual capacity of 70 million sterile ampoules.
18
M
Annual capacity of 18 million liquid vials.
2,2
M
Annual capacity of 3.5 million lyophilized vials.
20
M
Annual capacity of 20 million prefilled syringes.
100
M
Total annual manufacturing capacity of over 100 million units.
14K
M2
Total Manufacturing Area
Ampoule Production Area
Our Ampoule Production Area is designed for the manufacture of sterile injectable products in compliance with international quality standards. Equipped with modern filling, sealing, and inspection systems, our production line supports high product quality and process reliability. Through operations conducted in accordance with GMP principles, we offer flexible manufacturing solutions for different fill volumes and product types.
Vial Production Area
Our Vial Production Area is equipped with advanced technology that enables the high-precision manufacture of sterile products in liquid and powder forms. Critical quality parameters are continuously monitored and controlled throughout the manufacturing process. Our facility offers reliable and scalable manufacturing capacity for both our own products and contract manufacturing projects.
Lyophilized Vial Production Area
Our Lyophilized Vial Production Area employs advanced freeze-drying technologies for the manufacture of products with critical stability requirements. Controlled lyophilization processes preserve product quality while providing an extended shelf life and high process efficiency. With a design compliant with aseptic manufacturing requirements and a modern equipment infrastructure, the area enables production in accordance with international standards.
PFS (Prefilled Syringe) Production Area
Our Prefilled Syringe (PFS) Production Area is designed for the precise filling and assembly of ready-to-use sterile syringes. Prioritizing patient safety and ease of use, our manufacturing processes are conducted to ensure highly accurate dosing and product integrity. Supported by modern automation systems, our infrastructure can accommodate a wide range of product portfolios.
Terminal Sterilization
Our terminal sterilization capability enables products to be sterilized within their final packaging, supporting the highest level of microbiological assurance. Validated sterilization processes play an essential role in maintaining product safety and consistent quality. This approach prioritizes patient safety while contributing to full compliance with regulatory requirements.
QUALITY AND RELIABILITY
World-Class Quality Standards
At every stage of our manufacturing processes, we adhere to national and international quality standards. Through a risk-based approach, continuous improvement and operational excellence, we develop reliable manufacturing processes.
Explore Quality
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GMP Certificate
European GMP
ISO 9001
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OUR BUSINESS PARTNERS
Strengthening Our Manufacturing Capabilities Through Partnerships
Alongside its own licensed products, Dem Pharmaceuticals operates as a CMO manufacturing sterile products for both domestic and export markets. We actively collaborate with marketing authorization holders in Türkiye and abroad.
MANUFACTURING TECHNOLOGIES
Manufacturing Supported by Advanced Technology
At our manufacturing facility, we use modern technologies that support various stages of manufacturing—from ampoule, vial and lyophilized vial production to packaging, optical inspection and quality control.
Our manufacturing equipment and laboratory infrastructure are designed to meet the requirements of sterile manufacturing processes.
In 2022, the facility successfully completed the GMP inspection conducted by the Turkish Ministry of Health. Following the issuance of its GMP Certificate, the facility was officially opened.
In 2024, the facility obtained European GMP certification, further strengthening its compliance with international quality standards.
The facility currently provides contract manufacturing services as a CDMO (Contract Development and Manufacturing Organization) and actively collaborates with marketing authorization holders in Türkiye and abroad. The number of companies it serves continues to grow steadily.
Our manufacturing equipment and laboratory infrastructure are designed to meet the requirements of sterile manufacturing processes.
In 2022, the facility successfully completed the GMP inspection conducted by the Turkish Ministry of Health. Following the issuance of its GMP Certificate, the facility was officially opened.
In 2024, the facility obtained European GMP certification, further strengthening its compliance with international quality standards.
The facility currently provides contract manufacturing services as a CDMO (Contract Development and Manufacturing Organization) and actively collaborates with marketing authorization holders in Türkiye and abroad. The number of companies it serves continues to grow steadily.
Explore All Products
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01
Lyophilized Vial
Manufacturing Area
Manufacturing Area
Vial filling, stoppering and lyophilizer infrastructure.
02
Packaging
Systems
Systems
Optical inspection, blister packaging and cartoning.
03
Ampoule
Manufacturing
Manufacturing
Solution preparation, filtration, ampoule washing, filling and sealing.
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04
Quality Control &
Microbiology
Microbiology
HPLC, UV-Vis and FT-IR systems, as well as biosafety cabinets.
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A Network Strengthened by Global Partnerships
Through strong partnerships across different markets, Dem Pharmaceuticals transforms its expertise and manufacturing capabilities into collaborations that create value on an international scale.
With a commitment to long-term relationships and mutual trust, the company continues to expand its global network.
With a commitment to long-term relationships and mutual trust, the company continues to expand its global network.
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Growth Extending from Türkiye to the World
Dem Pharmaceuticals combines its robust infrastructure in Türkiye with its experience in global markets to expand its international presence.
As it enters new markets, the company maintains steady global growth with a focus on quality, sustainability and reliability.
As it enters new markets, the company maintains steady global growth with a focus on quality, sustainability and reliability.
Elektronİk Sİstemlerİmİz
Elektronik Sistemlerimiz
Üretim Tesisimizde tüm süreçler, kalite ve operasyon standartlarının sürekliliğini sağlamak amacıyla aşağıdaki elektronik kontrol sistemleriyle takip edilmektedir:
SAP
Tüm satın alma, üretim ve lojistik işlemleri, süreçlerin etkin ve kontrollü şekilde yönetilmesini sağlayan SAP yazılımı ile yürütülmektedir.
SAP
Tüm satın alma, üretim ve lojistik işlemleri, süreçlerin etkin ve kontrollü şekilde yönetilmesini sağlayan SAP yazılımı ile yürütülmektedir.
SAP
Tüm satın alma, üretim ve lojistik işlemleri, süreçlerin etkin ve kontrollü şekilde yönetilmesini sağlayan SAP yazılımı ile yürütülmektedir.
SAP
Tüm satın alma, üretim ve lojistik işlemleri, süreçlerin etkin ve kontrollü şekilde yönetilmesini sağlayan SAP yazılımı ile yürütülmektedir.
Elektronik Sistemlerimiz
Elektronik
Sistemlerimiz
Üretim tesisimizde tüm süreçler, kalite ve operasyon standartlarının sürekliliğini sağlamak amacıyla aşağıdaki elektronik kontrol sistemleriyle takip edilmektedir.
BMS
(Bina Yönetim Sistemi) Tüm havalandırma ve destek sistemleri, merkezi kontrol ve izleme sağlayan Bina Yönetim Sistemi (BMS) ile etkin şekilde yönetilmektedir.
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EMS
(Çevre İzleme Sistemi) Üretim, Kalite ve Depo alanlarında sıcaklık, nem ve basınç farkı gibi kritik kalite parametreleri izlenmekte ve kayıt altında tutulmaktadır.
QMex
Kalite Yönetim Sistemi; doküman, MBR, değişiklik, eğitim, DÖF ve sapma yönetimi süreçlerini kapsamaktadır.
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Farmakod
Ambalaj malzemelerine özel olarak verilen farmakodlarla, ambalajlama sırasında malzemelerin karışmasını engelleyen kontrol sistemidir.
İTS
Türkiye pazarında her bir kutunun takip edilebilmesi için tekil seri numarası atanmasında kullanılır.
CDS
Kalite Kontrol laboratuvarında bulunan HPLC ve GC gibi kromatografik donanımların ortak ağ üzerinden yönetilmesi için kullanılmaktadır.
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SPİS
(Çevre İzleme Sistemi) Üretim, Kalite ve Depo alanlarında sıcaklık, nem ve basınç farkı gibi kritik kalite parametreleri izlenmekte ve kayıt altında tutulmaktadır.