Explore our pharmaceutical-grade active ingredients, custom synthesis products, and specialized chemical solutions backed by rigorous cGMP quality standards.
An in-depth chemical breakdown of Liraglutide (15mg/vial or bulk powder), engineered for maximum metabolic stability, high target receptor affinity, and extended therapeutic half-life.
Liraglutide is a long-acting analog of human glucagon-like peptide-1 (GLP-1(7-37)), chemically modified to enhance self-association and albumin binding. By replacing Lysine at position 34 with Arginine (Arg34) and attaching a hexadecanoyl (palmitoyl) fatty acid chain to Lysine at position 26 via a L-glutamic acid spacer, Liraglutide achieves resistance to dipeptidyl peptidase-4 (DPP-4) degradation.
Liraglutide functions as a selective GLP-1 receptor agonist. It stimulates glucose-dependent insulin secretion, suppresses glucagon release, delays gastric emptying, and promotes satiety via central nervous system pathways. Offered in 15mg per vial lyophilized powder or bulk high-purity API format, this product is ideal for pharmaceutical research institutes, generic drug developers, and finished dosage form (FDF) manufacturers globally.
| Test Parameter | Analytical Method | Acceptance Criteria | Typical Batch Result |
|---|---|---|---|
| Appearance | Visual Inspection | White to off-white lyophilized powder | Conforms (White Powder) |
| Chemical Purity | RP-HPLC (UV at 220nm) | ≥ 99.0% (Custom ≥ 99.5%) | 99.68% |
| Mass Spectrometry (MS) | ESI-MS / MALDI-TOF | Monoisotopic Mass = 3751.20 ± 1.0 Da | 3751.22 Da |
| Peptide Content (Assay) | Elemental Nitrogen / HPLC | ≥ 85.0% (w/w) | 88.4% |
| Bacterial Endotoxins | LAL Kinetic Chromogenic | < 5.0 EU/mg | < 0.5 EU/mg |
| Residual Solvents | Headspace GC-MS | Meets ICH Q3C limits (Acetonitrile <410ppm, DMF <880ppm) | Below Quantification Limit |
| Water Content (Karl Fischer) | Coulometric KF Titration | ≤ 5.0% | 2.1% |
Exploring next-generation synthesis techniques, green chemical engineering, and advanced drug delivery compatibility that drive the future of metabolic therapeutics.
Transitioning from traditional step-by-step Solid-Phase Peptide Synthesis (SPPS) to block-coupling Liquid-Phase Peptide Synthesis (LPPS). This hybrid methodology decreases raw material consumption by 40%, significantly enhances segment purity, and eliminates truncation peptide impurities (such as Des-Ala or D-amino acid derivatives).
Implementing green solvents (e.g., 2-MeTHF, Green NMP substitutes) and automated continuous flow synthesis platforms. Up to 85% of organic solvents used in crude purification are recovered onsite, resulting in an eco-friendly manufacturing cycle that lowers carbon footprint while guaranteeing cost advantages for high-volume B2B clients.
Adapting 15mg Liraglutide API for specialized delivery devices, including multi-dose pen cartridges (18mg/3mL), long-acting biodegradable microspheres (PLGA-based depot injections), and novel oral co-formulations utilizing SNAC permeation enhancers to capture emerging biosimilar markets.
Strategic insights for pharmaceutical enterprises facing surging market demand, patent cliffs, and strict international drug authority mandates.
The exponential increase in global Type 2 Diabetes and weight management therapeutic adoption has created chronic shortages in peptide API manufacturing capacity. Gentolex addresses this critical market bottleneck by scaling up commercial production of Liraglutide 15mg API and intermediate building blocks. Our industrial facilities provide contract partners with secured supply quotas, protecting commercial launches against global raw material bottlenecks.
Entering generic or biosimilar peptide markets requires rigorous proof of sameness. Under US FDA 505(b)(2) and ANDA peptide guidance, applicants must prove that synthetic Liraglutide has identical secondary structures and impurity profiles compared to the reference listed drug (RLD). Gentolex provides full comparative analytical packages—including 2D-NMR, Circular Dichroism (CD), and Fourier-Transform Infrared Spectroscopy (FTIR)—streamlining your regulatory submission process.
Inside Gentolex’s 250,000 m² state-of-the-art intelligent manufacturing complex built to international cGMP benchmarks.
Constructed to meet US FDA, EU GMP, and NMPA standards. Features Class 100,000 cleanrooms, automated freeze-drying suites, and dedicated multi-kilogram peptide synthesis reactors designed for continuous batch scale-up.
Integrated Distributed Control Systems (DCS) monitor reaction parameters, temperatures, coupling times, and flow rates in real-time. Inline PAT technology guarantees batch-to-batch reproducibility with minimal human error.
From protected FMOC amino acid raw materials to custom peptide intermediates, crude peptide synthesis, preparative HPLC purification, and final sterile vial freeze-drying—our integrated chain reduces production lead times by 35%.
Creating global opportunities by connecting life science leaders with guaranteed chemical products and comprehensive supply chain solutions.
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.
An overall factory construction area of 250,000 square meters under international standard to offer flexible, scalable and cost-effective solutions.
View DetailsFlexible, scalable and cost-effective solutions constructed under strict international standards.
Extensive range of APIs for development study and commercial application with cGMP standard supported with full documentation and certificates.
Tailored procurement services eliminating single-point contact complexities with high-tier supply chain resources.
AssURING seamless cross-border delivery and local regulatory support across North America, Europe, LATAM, and Africa.
To eliminate communication delays and cultural barriers, Gentolex operates dedicated regional offices in Mexico and South Africa. Our local representatives facilitate rapid customs clearance, local invoicing, and face-to-face technical support.
Liraglutide 15mg API requires strict temperature maintenance (-20°C for long-term bulk storage, 2–8°C for ready-to-ship lyophilized vials). We utilize validated VIP (Vacuum Insulation Panel) packaging with IoT real-time temperature loggers.
Every shipment is backed by complete analytical data packages: Certificate of Analysis (CoA), High-Resolution LC-MS, HPLC Chromatograms, Residual Solvent GC Reports, Heavy Metal Analysis, and Stability Data under ICH Q1A(R2) conditions.
Stay informed with technical whitepapers and industry news from our lead scientific research teams.
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View DetailsClear answers regarding Liraglutide 15mg sourcing, analytical verification, custom synthesis, and bulk logistics.
Our standard commercial batch purity for Liraglutide 15mg is ≥ 99.0% by Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC), with high-grade custom batches reaching ≥ 99.5%. Every batch is rigorously characterized via Electrospray Ionization Mass Spectrometry (ESI-MS) to verify the exact molecular mass (3751.20 Da), GC-MS for residual solvent control, and LAL assays for bacterial endotoxins (<5.0 EU/mg).
Gentolex provides comprehensive regulatory support packages, including Type II Drug Master Files (DMF) for US FDA submissions, CEP registration support in Europe, and complete CTD Module 3 dossier documentation. We perform 2D-NMR, CD spectroscopy, and aggregation profiling to assist clients in establishing structural sameness under US FDA peptide guidance.
For evaluation and analytical testing, we offer sample quantities starting from 15mg vials up to 10g research batches. For commercial manufacturing, our flexible CDMO capabilities support scale-up from 100g to multi-kilogram production runs. Standard lead time for stock items is 3–5 business days, while custom synthesis orders typically take 3–4 weeks.
Bulk Liraglutide API is packaged in double food-grade polyethylene bags inside light-proof aluminum foil vacuum bags, sealed within heavy-duty fluorinated containers. Lyophilized vials (15mg) are stoppered under inert nitrogen atmosphere. All products ship via temperature-monitored cold-chain express (with gel ice packs or dry ice) maintaining temperatures below -20°C or 2–8°C throughout transit.
Yes. Beyond API supply, Gentolex offers comprehensive FDF license-out options, pre-formulated liquid solution technology, cartridge filling process validation (18mg/3mL), and turnkey laboratory/production line setup consultation for regional pharmaceutical companies.
Explore additional specialized peptides, weight management APIs, and chemical raw materials from our factory production lines.
