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In the rapidly evolving global anti-obesity and metabolic healthcare sector, Orlistat (CAS 96827-07-5) remains a cornerstone active pharmaceutical ingredient (API). As a potent, specific, and long-acting gastric and pancreatic lipase inhibitor, Orlistat exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine site of lipases. In an era where metabolic disorders present unprecedented public health challenges globally, bulk procurement of pharmaceutical-grade Orlistat API from verified manufacturers, factory direct suppliers, and specialized wholesalers has become a strategic priority for multinational generic drug producers, finished dosage form (FDF) contract manufacturers, and dietary supplement brand owners.
Gentolex Group stands at the forefront of this industrial chemical landscape. With an overall factory construction footprint spanning 250,000 square meters operating under rigorous cGMP and ISO 9001:2015 frameworks, Gentolex bridges the critical gap between complex organic chemical synthesis and international drug compliance. As a primary Orlistat wholesaler and factory-direct company, we provide scalable end-to-end supply chain infrastructure, custom particle micronization, comprehensive regulatory technical dossiers (including Drug Master Files), and turnkey localized logistics for clients spanning over ten countries across North America, Europe, Latin America, and Africa.
Direct sourcing from our multi-ton synthesis facilities reduces raw material expenditures by up to 30%, ensuring competitive pricing for generic brand commercialization.
Every batch of Orlistat API undergoes rigorous HPLC, NMR, and GC residual solvent testing, strictly adhering to United States Pharmacopeia (USP) and European Pharmacopoeia (EP) specifications.
We accelerate market access by offering complete CTD-formatted regulatory dossiers, stability data under ICH guidelines, and active US FDA DMF filing support.
Orlistat (tetrahydrolipstatin) is a hydrogenated derivative of lipstatin derived from Streptomyces toxytricini. Chemically designated as (S)-((S)-1-((2S,3S)-3-hexyl-4-oxooxetan-2-yl)tridecan-2-yl) 2-formamido-4-methylpentanoate, its intricate stereochemical structure demands precision enzymatic and chemical synthesis methods to prevent degradation and unwanted optical isomers.
| Analytical Parameter | Pharmacopoeial Standard (USP / EP) | Gentolex Factory Batch Results | Testing Method / Instrument |
|---|---|---|---|
| Chemical Name | Orlistat / Tetrahydrolipstatin | CAS No. 96827-07-5 | Structural Identification |
| Appearance | White to off-white crystalline powder | Conforms (Pure Crystalline Powder) | Visual Inspection |
| Assay (Drying Basis) | 98.0% - 102.0% | 99.6% - 100.2% | HPLC (High Performance Liquid Chromatography) |
| Melting Point | 40.0°C to 45.0°C | 43.5°C - 44.5°C | Capillary Melting Apparatus |
| Specific Optical Rotation | -43.0° to -48.0° | -45.8° | Polarimetry |
| Individual Impurity | ≤ 0.14% | < 0.05% | Reverse-Phase HPLC |
| Total Impurities | ≤ 1.0% | < 0.3% | Reverse-Phase HPLC |
| Heavy Metals | ≤ 10 ppm | < 5 ppm | ICP-MS |
| Residual Solvents | Meets ICH Q3C Guidelines | Strictly Below Limit (Acetone < 100ppm) | GC-Headspace |
Because raw Orlistat API features a relatively low melting point (~43°C), traditional high-speed mechanical milling can introduce localized thermal stress, causing melting, agglomeration, or crystalline structural shift. Gentolex utilizes specialized cryo-milling and fluid-bed jet micronization equipped with cold-nitrogen gas streams. This yields precise particle size distributions (D90 < 20μm or customized according to customer softgel/capsule compression requirements) while maintaining complete crystal lattice integrity.
Global drug manufacturers operating in today's margin-sensitive pharmaceutical market require robust supply chain resilience, absolute traceability, and competitive pricing. China has consolidated its status as the world's primary producer of active pharmaceutical ingredients due to integrated upstream key starting material (KSM) availability, advanced chemical synthesis technology, and large-scale industrial infrastructure.
Our 250,000 square meter integrated facility maintains direct synth-pipeline controls for key starting materials (KSMs) required in Orlistat synthesis, such as leucine derivatives and hexanal precursors. This backward integration insulates global buyers from volatile price fluctuations and sudden intermediate shortages, delivering continuous supply commitments.
Gentolex has pioneered sustainable biocatalytic and stereoselective hydrogenation pathways that drastically reduce hazardous solvent consumption during synthesis. Modern catalytic processes yield higher reaction enantioselectivity, driving chemical assay purity while reducing overall energy expenditures and carbon footprint.
Equipped with multi-thousand-liter glass-lined and stainless steel reaction vessels, Gentolex achieves multi-ton annual outputs of Orlistat API. Whether clients require small-batch pilot validation samples (1-5kg) or full-scale commercial container shipments, our production lines scale seamlessly without batch-to-batch variation.
Orlistat API demands controlled temperature handling during storage and international shipping to preserve physical stability. Gentolex maintains temperature-regulated warehouse environments (stored below 8°C or -20°C as required) and deploys validated thermal packaging with real-time IoT temperature monitoring for global air and sea transit.
Navigating market-entry regulations for pharmaceutical ingredients requires meticulous documentation and localized technical assistance. To serve brand owners, generic drug manufacturers, and distributors efficiently, Gentolex Group has established localized service frameworks and strategic international regional offices.
Our local representatives in Mexico handle localized regulatory consultation, COFEPRIS filing alignment, fast-track custom clearance, and localized inventory buffering for Latin American pharmaceutical brands.
Serving sub-Saharan healthcare markets, our South African hub coordinates technical dossiers, SAHPRA compliance data, localized warehousing, and flexible payment gateway support for regional importers.
Gentolex provides clients with Module 3 CTD dossier files, Certificates of Analysis (CoA), Stability Data (Accelerated & Long-term), Nitrosamine Risk Assessments, and Process Validation Reports for seamless authority approvals.
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.
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.
Dedicated analytical R&D laboratories to handle custom molecular synthesis, peptide modification, and targeted drug formulation development.
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.
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