Explore our premier portfolio of high-purity APIs, peptide intermediates, and specialized pharmaceutical active ingredients engineered to international regulatory standards.
As a leading OEM Powder Orlistat Supplier & Company, Gentolex delivers pharmaceutical-grade Active Pharmaceutical Ingredients (APIs) designed for high bioavailability, exceptional physical stability, and seamless solid-dosage integration. Orlistat (CAS 96829-58-2) is a potent, specific, and long-acting gastric and pancreatic lipase inhibitor designed for metabolic weight management, obesity management, and associated hyperlipidemia treatments.
Orlistat acts locally within the lumen of the stomach and small intestine by forming a covalent bond with the active serine residue site of gastric and pancreatic lipases. Inactivated enzymes are rendered incapable of hydrolyzing dietary fat in the form of triglycerides into absorbable free fatty acids and monoglycerides. Consequently, approximately 30% of ingested fat passes unabsorbed through the gastrointestinal tract, enabling effective non-systemic calorie reduction.
Our OEM Orlistat powder manufacturing leverages specialized crystallization techniques to produce Form I stable polymorphs, ensuring zero crystal structure transition during storage or wet granulation processes. We offer customized Particle Size Distribution (PSD) profiles, including ultra-micronized grades (D90 < 10 µm) for optimal dispersion in micro-pellet formulations, and standard granular grades (D90: 80–150 µm) engineered for direct compression and capsule filling.
| Test Parameters | Acceptance Criteria | Analytical Test Method |
|---|---|---|
| Chemical Name | (S)-((S)-1-((2S,3S)-3-hexyl-4-oxooxetan-2-yl)tridecan-2-yl) 2-formamido-4-methylpentanoate | IUPAC Standard |
| CAS Registry Number | 96829-58-2 | CAS Chemical Index |
| Appearance | White to off-white crystalline powder | Visual Inspection |
| Assay Content (Dry Basis) | 98.0% – 102.0% w/w | HPLC / Gradient Elution |
| Melting Point Range | 40.0°C to 45.0°C | Differential Scanning Calorimetry (DSC) |
| Related Impurities | Individual Unknown ≤ 0.10%; Total Impurities ≤ 0.50% | High-Performance Liquid Chromatography |
| Heavy Metals & Solvents | Heavy Metals ≤ 10 ppm; Residual Solvents comply with ICH Q3C | ICP-MS / Headspace Gas Chromatography |
Gentolex operates an extensive industrial chemical manufacturing ecosystem spread over a total factory construction area of 250,000 square meters designed to international cGMP and ISO standards. Our strategic operational model bridges raw material synthesis, chemical processing, quality assurance, and international logistics, ensuring global partners receive consistent product quality without supply disruption.
By producing critical synthetic intermediates in-house, Gentolex mitigates raw material market volatility and secures uninterrupted production cycles. This backward integration guarantees full traceability from early-stage chemical synthesis to final micronized Orlistat powder active ingredients.
Our modern manufacturing lines implement advanced catalytic reduction and solvent recycling systems, reducing overall environmental impact and operating costs. Our facility aligns with stringent green chemistry requirements and international environmental safety regulations.
From initial pilot-scale batches (10kg–50kg) for research and clinical trial formulations to multi-ton commercial quantities, our facilities offer total batch consistency, customizable packaging specs, and comprehensive technical consultation tailored for brand owners.
Global pharmaceutical buyers require verifiable proof of quality, regulatory standard compliance, and thorough dossier backings. Gentolex maintains robust quality management systems (QMS) ensuring all batch releases meet global requirements across Europe, North America, Latin America, and Africa.
We supply full dossier support formatted to Common Technical Document (CTD / ACTD) specifications. Available documentation includes:
Beyond bulk chemical supply, Gentolex offers Finished Dosage Form (FDF) license-out models, technical consultations, product line layout, and laboratory configuration services. We support clients looking to set up local encapsulation, tableting, or micro-pellet coating facilities worldwide.
The global weight management market is experiencing unprecedented evolution. While injectable GLP-1 receptor agonists (such as Semaglutide and Tirzepatide) have gained widespread attention, Orlistat remains the gold standard for oral, non-systemic anti-obesity therapy due to its established safety profile, OTC accessibility, and cost-effectiveness.
| Evaluation Parameter | Oral Powder Orlistat (CAS 96829-58-2) | Injectable GLP-1 Agonists (e.g. Tirzepatide/Semaglutide) |
|---|---|---|
| Route of Administration | Oral Solid Dosage (Capsule / Tablet / Pellet) | Subcutaneous Injection (Weekly / Daily) |
| Systemic Bioavailability | Negligible (<1% systemic absorption) | High systemic systemic receptor activation |
| Regulatory OTC Status | Approved for Over-The-Counter (60mg) & Prescription (120mg) | Strict Prescription Only (Rx) |
| Cold-Chain Logistics | Standard ambient/controlled storage (No cold chain needed) | Mandatory 2°C–8°C refrigerated supply chain |
| Patient Unit Cost | Highly Economical / Accessible for Mass Consumption | High Cost / Limited Global Accessibility |
Our OEM Powder Orlistat is customized to meet diverse localized commercial markets, supporting pharmaceutical manufacturers, dietary supplement brands, and health product distributors worldwide.
Ideal for mass-market OTC launch in pharmacy retail chains. Designed for consumption alongside fat-containing meals to block fat absorption without systemic metabolic burden.
Targeted for clinical therapy, metabolic syndrome management, and physician-supervised weight management programs. High bio-equivalence to reference listed drugs (RLDs).
Micro-pellet technological designs that control drug release precisely inside the small intestine, improving patient compliance by decreasing gastrointestinal side-effects.
Gentolex’s overarching goal is to create opportunities connecting the global pharmaceutical market with guaranteed products and elevated services. Up to date, Gentolex Group serves clients across more than 10 countries, featuring dedicated representative branches established in Mexico and South Africa to facilitate seamless localized customer service, customs clearance support, and immediate stock dispatch.
Comprehensive peptide capabilities including solid-phase peptide synthesis (SPPS), liquid-phase synthesis, and custom sequence modifications to support innovative biotech research.
Turnkey finished dosage form licensing, providing clients with access to fully validated product registration dossiers for rapid regional commercial launches.
End-to-end guidance on setting up specialized chemical facilities, analytical laboratories, and manufacturing production lines under cGMP compliance.
For clients preferring to eliminate multi-vendor management complexities, Gentolex provides customized procurement solutions backed by China's top chemical infrastructure.
Our standard MOQ for commercial Orlistat powder active pharmaceutical ingredient (CAS 96829-58-2) is 10kg. However, for initial formulation R&D, laboratory testing, or qualification trials, we support evaluation sample quantities starting at 1kg.
Gentolex manufactures stable Orlistat Form I powder using customized anti-solvent crystallization processes. Stability is monitored according to ICH Q1A(R2) standards, ensuring resistance to phase transformation and degradation when stored under recommended controlled room temperature conditions.
Yes, we provide tailored micronization services to match your exact solid dosage requirements. We offer micronized powder (D90 < 15 µm) for optimized blend uniformity, as well as granular powder optimized for high-speed encapsulation and tableting equipment.
Every batch is supplied with a comprehensive Batch Certificate of Analysis (CoA), Safety Data Sheet (MSDS/SDS), Certificate of Origin (COO), and BSE/TSE declaration. Full Drug Master File (DMF) documentation is available to qualified regulatory teams upon request.
With established representative offices in Mexico and South Africa, Gentolex delivers dedicated regional sales consultation, local currency documentation support, customs clearance assistance, and streamlined logistical execution across LATAM and African continents.
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