Primary clinical-grade nucleic acid therapeutic raw materials and specialty modified monomers supplied directly to pharmaceutical manufacturing complexes across Istanbul and the Marmara region.
Istanbul, positioned at the geopolitical and commercial crossroads of Europe, the Middle East, and Asia, has rapidly transformed into a vital epicenter for pharmaceutical R&D, generic medicine manufacturing, and advanced biotherapy commercialization. Guided by the Turkish Medicines and Medical Devices Agency (TİTCK) aligned with European Medicines Agency (EMA) standards, local biopharmaceutical enterprise centers—such as the Tuzla Chemical and Industrial Zones and ITU ARI Teknokent—are scaling up operations in nucleic acid therapeutics, small interfering RNA (siRNA), antisense oligonucleotides (ASO), and messenger RNA (mRNA) technologies.
Information Gain Insight: Sourcing high-purity Oligonucleotide Active Pharmaceutical Ingredients (APIs) in Istanbul requires navigating stringent phosphoramidite chemistry requirements, specialized purification techniques (RP-HPLC/IEX-HPLC), and cold-chain supply chain integrity. Gentolex connects Turkish drug formulators with world-class cGMP oligonucleotide synthesis facilities.
As therapeutic applications of therapeutic oligonucleotides expand beyond rare genetic disorders into cardiovascular health (e.g., Inclisiran sodium targeting PCSK9), metabolic conditions, and oncology, local formulation and finish product (FDF) licensees in Turkey demand reliable chemical purity (>98.5%), precise sequence integrity, and complete regulatory dossiers (DMF/CEP format). Our localized supply framework provides seamless integration from pilot-scale research to multi-kilogram industrial production.
Comprehensive breakdown of oligonucleotide manufacturing technology, backbone modifications, and quality assurance metrics.
The core manufacturing architecture relies on automated phosphoramidite chemistry. High-throughput automated synthesizers utilize controlled pore glass (CPG) or macroporous polystyrene (MPP) solid supports to build sequences iteratively from 3' to 5'. For commercial-scale bulk supply in Istanbul, hybrid LPOS or fragment coupling techniques are utilized to increase yield while controlling byproduct profile.
Rigorous analytical testing ensures compliance with international pharmacopeial standards (USP/Ph. Eur.):
Combining high-capacity automated chemical synthesis with robust global logistics networks to de-risk pharmaceutical raw material procurement.
The global demand for advanced therapeutic oligonucleotides requires massive raw material infrastructure—from specialized phosphoramidite building blocks to multi-kilogram cGMP APIs. Gentolex leverages an overall factory construction footprint of 250,000 square meters operating under strict cGMP and ISO guidelines, offering unmatched economies of scale.
AI-driven continuous monitoring of solvent moisture, coupling efficiency, and cleavage/deprotection kinetics ensuring zero batch-to-batch variation.
Backward-integrated production of key raw materials including protected nucleosides, cyanoethyl phosphoramidites, and solid supports.
Validated temperature-controlled shipping (-20°C to -80°C) with live IoT tracking straight to Istanbul Airport (IST) and custom bonded warehouses.
Navigating Turkish TİTCK regulations, quality audits, and laboratory setup consultation.
Entering the Turkish pharmaceutical market requires rigorous compliance with health authorities. Gentolex provides full technical and regulatory backing to ensure smooth registration and commercial rollout:
Complete CTD-format Drug Master Files (DMF), Certificates of Analysis (CoA), Stability Data (ICH climatic zones II and IVb), and BSE/TSE-free certifications.
Finished Dosage Form (FDF) licensing opportunities for Turkish pharma manufacturers seeking turn-key formulations for peptides and therapeutic nucleic acids.
On-site and remote technical consultation for establishing analytical control labs, cleanroom standards, and HPLC method validation in Istanbul.
Explore our expanded list of APIs, protected amino acids, and custom chemical building blocks available for bulk procurement in Istanbul.
Our main services focus on supplying peptides APIs and Custom Peptides, FDF license out, Technical Support & Consultation, Product Line and Lab Setup, Sourcing & Supply Chain Solutions.
An overall factory construction area of 250,000 square meters under international standard to offer flexible, scalable and cost-effective solutions for clients in Istanbul and globally.
Gentolex offers an extensive range of APIs and intermediates for development study and commercial application with cGMP standard from long-term collaborations. Documents and Certificates are supported to customers worldwide.
Full spectrum contract research and technical development tailored to complex modified oligonucleotides, novel drug delivery systems, and peptide backbone engineering.
For those clients who prefer to avoid the complexity of dealing with multiple points of contact, we provide extra customized procurement services with the most superior and comprehensive supply chain sources.
Gentolex’s goal is to create opportunities connecting the world with better services and guaranteed products. Up to date, Gentolex Group has been serving customers from more than 10 countries, specially, representatives are established in Mexico and South Africa. Our main services focus on supplying peptides APIs and Custom Peptides, FDF license out, Technical Support & Consultation, Product Line and Lab Setup, Sourcing & Supply Chain Solutions.
Stay informed with the latest scientific publications, analytical breakthroughs, and technical guides published by Gentolex specialists.
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View DetailsTechnical and logistical insights addressing common inquiries regarding oligonucleotide API procurement and importation into Turkey.
