Insulin Analog and rRNA Oligo Synthesis
Licensed Outsourcing Facility providing high-quality, cGMP-compliant sterile injectables. We offer bulk supply of GLP-1 agonists and Insulin for clinic office use. Secure your medical facility's supply chain today
At Zeptide Pharma, we ensure your path to market is seamless by getting small molecule manufacturing right the first time. By integrating end-to-end pharmaceutical development solutions with the deep scientific expertise required for complex formulations, we transform challenges into clinical success. With over 25 years of industry leadership, we provide the stability and innovation your molecule deserves.
Our Core Synthesis Capabilities
- Custom DNA Oligonucleotides:Â High-fidelity synthesis for gene assembly, diagnostic probes, and therapeutic applications.
- GMP RNA Synthesis: Specialized production of siRNA, sgRNA for CRISPR, and Aptamers, featuring extensive modification options.
- Modified Oligos: Expert incorporation of phosphorothioate (PS) linkages, 2’-OMe, 2’-F, and LNA to enhance stability and potency.
- Scalable Manufacturing: Seamless transition from R&D pilot batches (mg) to large-scale pharma-grade manufacturing (kg).
Why Choose Our Pharma-Grade Oligonucleotides?
To rank as a leader in nucleic acid therapeutics, we prioritize quality and compliance at every step:
- ISO-Certified & cGMP Compliant:Â Our processes adhere to strict global regulatory guidelines to ensure safety and efficacy for human clinical trials.
- Advanced Purification: We use high-performance HPLC and Ultrafiltration to ensure maximum purity and the removal of truncated sequences.
- Comprehensive Analytical Testing: Every batch undergoes rigorous Mass Spectrometry (MS), Capillary Electrophoresis (CE), and endotoxin testing.
- Full Documentation Support: We provide complete Chemistry, Manufacturing, and Controls (CMC) documentation to streamline your IND (Investigatory New Drug) applications.
World Health Organization Global Reach & Regulatory Excellence
We facilitate the cGMP manufacture and global supply of finished drug products to premier markets, including North America, Europe, Asia, and the Middle East. Our commitment to compliance is validated by a flawless track record of inspections from the world’s most stringent global regulatory authorities, including:
- USFDA, MHRA (UK), & Health Canada
- ANVISA (Brazil) & PMDA (Japan)
- PIC/S, GMP, TFDA, and the Gulf Cooperation Council (GCC)
