About Us
Pioneering Drug Solutions
Drawing on our vast expertise in oligonucleotides, we excel in the creation of groundbreaking drug substances and final products. Our thorough similarity assessments against the Reference Listed Drug (RLD) guarantee that our offerings adhere to the highest international quality benchmarks. With a meticulously crafted CTD dossier primed for global regulatory submissions, we are poised to make significant contributions to the pharmaceutical sector. Collaborate with us to enhance your product lineup and propel the future of healthcare forward.
F E A T U R E S
How a Vertical Integrated Generic works
Drug Substance (DS) Development
Secure raw materials and optimize solid-phase synthesis for high-purity crude products.
IP-Compliant Process
Develop synthetic routes that avoid active patents to ensure Freedom to Operate.
Sameness & Characterization
Use high-end analytics (LC-MS/NMR) to prove chemical identity to the reference drug.
Drug Product (DP) Development
Stabilize the molecule into its final injectable or lyophilized dosage form.
GMP Production & Exhibition
Scale up at a CMO to produce GMP batches for formal stability testing.
Global Submission & Filing
File CTD dossiers (ANDA/MAA) with health authorities for market approval.
Nusinersen: Ready for Filing
| Readiness | ||
|---|---|---|
| ✓ US DMF | ✓ EU ASMF | ✓ GMP Site |
| ✓ 24 months+ Stability | ✓ Non-infringing | ✓ Impurity Profile |
| ✓ Sameness Study | ✓ Out-Licensing | ✓ Affordable Cost |
Branded CMO
Asymchem Group is a premier global CDMO providing integrated, end-to-end solutions for complex drug development. Sinuotides has strategically partnered with Asymchem to leverage their world-class infrastructure for the scaled-up manufacturing and global supply of our high-quality oligonucleotide portfolio.
Asymchem Group is a premier global CDMO providing integrated, end-to-end solutions for complex drug development. Sinuotides has strategically partnered with Asymchem to leverage their world-class infrastructure for the scaled-up manufacturing and global supply of our high-quality oligonucleotide portfolio.
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