Explore our flagship active pharmaceutical ingredients, custom peptide formulations, and specialized drug products manufactured under strict global regulatory standards.
The global metabolic healthcare landscape is undergoing a systemic paradigm shift. As obesity rates continue to surge globally, targeting metabolic syndrome has transitioned from an elective lifestyle dynamic to a primary healthcare directive. Within this domain, Orlistat (Tetrahydrolipstatin) remains the premier, non-systemic, peripherally acting pancreatic and gastric lipase inhibitor approved for over-the-counter (OTC) and prescription (Rx) therapeutic regimens.
Unlike systemic metabolic therapeutics such as injectable GLP-1 receptor agonists, Orlistat exerts its biological activity locally within the lumen of the stomach and small intestine. By forming a covalent bond with the active serine site of gastric and pancreatic lipases, Orlistat inactivates these enzymes, preventing the hydrolysis of dietary triglycerides into absorbable free fatty acids and monoglycerides. Consequently, approximately 30% of ingested dietary fat passes unabsorbed through the gastrointestinal tract.
This unique non-systemic safety profile makes Orlistat a resilient, indispensable asset in multinational pharmaceutical brand portfolios. Global demand for high-purity Orlistat API (Active Pharmaceutical Ingredient) and finished dosage forms (FDF)—including 60mg OTC capsules, 120mg Rx capsules, and oral micro-pellets—is expanding rapidly across North America, Latin America, Europe, Africa, and Southeast Asia.
Commercial production of Orlistat requires rigorous control over stereocenters, impurity profiles, crystal polymorphism, and particle size distribution (PSD) to maintain optimal dissolution dynamics.
Orlistat is synthetically derived via the catalytic hydrogenation of lipstatin, a natural lipase inhibitor produced by fermentation of Streptomyces toxytricini. Industrial OEM mastery requires precision fermentation broth recovery and bio-hydrogenation control.
With four chiral centers, maintaining stereospecificity is paramount. Advanced HPLC and GC testing methods ensure strict compliance regarding related substances (Impurity A, Impurity B, and diastereomers) according to USP/Ph. Eur. limits.
Because Orlistat API exhibits low aqueous solubility, fluid-energy micronization is applied to engineer particle size (D90 < 10 µm). This drastically enhances contact surface area in gastrointestinal fluids for uniform lipase binding.
| Specification Parameter | Ph. Eur. / USP Standard | Gentolex OEM Quality Target | Analytical Method |
|---|---|---|---|
| Chemical Identity | Tetrahydrolipstatin (C29H53NO5) | Conforms to Reference Standard | FTIR / HPLC Retention Match |
| Assay (Drying Basis) | 97.0% – 102.0% | 99.2% – 101.5% | High-Performance Liquid Chromatography (HPLC) |
| Melting Point | 43.0°C to 45.0°C | 44.0°C – 44.8°C | Capillary Melting Range / DSC |
| Individual Impurity | NMT 0.5% | NMT 0.15% | Reverse-Phase HPLC-UV |
| Total Impurities | NMT 1.0% | NMT 0.4% | Validated RP-HPLC Method |
| Heavy Metals / Residual Solvents | Meets ICH Q3A/Q3C Requirements | Ultra-low limits (PPM Level) | ICP-MS / Headspace Gas Chromatography (GC) |
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.
Custom OEM capsule encapsulation, enteric micro-pellet coating technology, dissolution rate tuning, and formulation scaling tailored for regional pharmaceutical regulatory filings.
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.
We offer full-service OEM production for hard gelatin and HPMC vegetable capsules. Formulations include standard 60mg and 120mg strengths engineered with optimal disintegrants to guarantee physiological efficacy.
Our specialized fluid-bed granulation and extrusion-spheronization technologies yield Orlistat sustained-release and targeted gastro-resistant pellets for optimized release profiling.
Direct raw material sourcing for global pharmaceutical manufacturers requiring high-purity API supported by complete analytical documentation, validation data, and stability dossiers.
Navigating international regulatory bodies requires rigorous documentation. OEM partners gain access to complete regulatory registration packages designed to streamline local health authority approval.
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.
Strategic Global Distribution & Facility Network
Exploring advanced drug delivery platforms, combination metabolic therapeutics, and sustainable green chemistry synthesis routes.
Transitioning traditional chemical synthesis steps into enzyme-catalyzed transformations. Reduces heavy solvent consumption and achieves carbon-neutral manufacturing footprints.
Co-formulating Orlistat with complementary metabolic regulators (e.g., lipid-modulating compounds) in multi-layer tablets to target multi-pathway weight management.
Development of SEDDS (Self-Emulsifying Drug Delivery Systems) to optimize local gut dispersion while mitigating common gastrointestinal tolerability issues.
Integrating end-to-end batch tracking via digital ledger tech from raw fermentation input to final consumer shelf dispatch.
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High-purity building blocks, specialized peptides, and advanced pharmaceutical ingredients for global commercial applications.
