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Deflazacort (CAS Registry Number: 14484-47-0; Chemical Formula: C25H31NO6) is an oxazoline derivative of prednisolone possessing potent anti-inflammatory and immunosuppressive properties. Unlike conventional systemic corticosteroids such as prednisone or dexamethasone, Deflazacort exhibits a unique heterocyclic ring structure—specifically an oxazole ring fused at the C-16 and C-17 positions of the steroid backbone. This subtle stereochemical modification dramatically shifts its pharmacological profile, leading to reduced interference with carbohydrate metabolism, minimized bone mineral density (BMD) depletion, and a lower incidence of cushingoid side effects during chronic administration.
The global demand for Deflazacort active pharmaceutical ingredient (API) has experienced steady upward trajectories, fueled by expanding Orphan Drug status designations across North America and Europe, escalating autoimmune disease diagnoses, and the ongoing optimization of oral solid dosage (OSD) manufacturing protocols. However, the procurement of Deflazacort requires meticulous oversight of stereospecific chemical synthesis, heavy metal catalyst residues, and polymorphic crystal control.
As a leading China Deflazacort Manufacturer, Gentolex Group bridges the gap between complex multi-step organic synthesis and commercial-scale global distribution. By leveraging fully integrated backward intermediate production (from precursor phytosterols to advanced pregnane intermediates), Chinese manufacturers offer unparalleled supply chain security, cost mitigation, and strict compliance with International Council for Harmonisation (ICH) guidelines.
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.
State-of-the-art process development laboratory, chiral separation facilities, and process analytical technology (PAT) integration for modern bio-therapeutics.
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.
Trusted Global Network & Strategic Supply Operations
Achieving pharmaceutical-grade Deflazacort API requires precise control over stereocenters and microbial dehydrogenation steps. Below is the multi-stage technical synthesis roadmap deployed in our China manufacturing centers.
Starting from 11β,17α,21-trihydroxypregna-1,4-diene-3,20-dione precursors derived via green fermentation from plant phytosterols.
Regiospecific condensation with acetonitrile derivatives under controlled acidic catalysis to construct the [17,16-d]oxazole heterocycle system.
Selective esterification at the C-21 hydroxyl site using acetic anhydride, followed by multi-stage recrystallization in pharmaceutical grade solvents.
Fluid-energy jet milling to achieve customized particle size distribution (PSD) tailored for tablet formulation or oral suspension suspension stability (d90 < 10 µm).
| Test Parameter | Acceptance Criteria | Methodology |
|---|---|---|
| Appearance | White to off-white crystalline powder | Visual Inspection |
| Chemical Identification | Conforms to Reference Standard | FTIR / 1H-NMR |
| HPLC Assay (Dried Basis) | 98.0% – 102.0% | RP-HPLC (ICH Q2) |
| Related Substances (Impurities) | Impurity A ≤ 0.15% Any Unspecified ≤ 0.10% Total Impurities ≤ 0.50% |
High-Performance Liquid Chromatography |
| Chiral Purity | Enantiomeric Excess > 99.5% | Chiral HPLC |
| Residual Solvents | Complies with ICH Q3C Limits | GC-HS (Headspace) |
| Heavy Metals / Elements | Complies with ICH Q3D | ICP-MS |
In an era of dynamic regulatory frameworks and volatile supply chain conditions, enterprise procurement teams require robust strategic risk management frameworks. Sourcing Deflazacort API from verified Chinese manufacturers provides distinct competitive advantages when coupled with end-to-end quality assurance.
Comprehensive regulatory documentation packages including US DMF (Drug Master File Type II), CEP / EDMF for European submissions, ASMF, and NMPA registration dossiers. We assist clients through formal deficiency letters and agency audits.
Dissolution rates directly govern the bioavailability of Deflazacort in solid dosages. We offer tailored particle size engineering—ranging from standard unground powders to ultra-fine micronized grades tailored for immediate or modified-release tablets.
To guard against global logistics bottlenecks, Gentolex operates regional distribution channels and bonded warehouse agreements, supporting vendor-managed inventory (VMI) arrangements for strategic enterprise procurement partners.
Navigating varying regional pharmacopeial standards (USP, Ph. Eur., IP) is a prerequisite for seamless API integration. Gentolex Group maintains strong regional presence across critical emerging and established markets.
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View DetailsIn-depth answers to critical procurement, regulatory, and chemical synthesis inquiries from QA managers and pharmaceutical buyers.
Deflazacort is an oxazoline derivative of prednisolone. The introduction of the oxazole ring alters its pharmacodynamics: while maintaining strong anti-inflammatory efficacy, it causes lower calcium loss from bones, results in fewer disruptions to glucose tolerance, and demonstrates a lower propensity for sodium retention compared to conventional systemic steroids.
We supply full Drug Master Files (DMF), Certificate of Analysis (CoA), Batch Manufacturing Records (BMR), Method Validation Protocols, Elemental Impurity Risk Assessments (ICH Q3D), and Residual Solvent Reports (ICH Q3C). EDMF / CEP assistance is also provided upon qualification.
Yes, we specialize in physical property customization. Our jet-milling technology allows us to provide micronized Deflazacort API with d90 < 10 microns or d50 < 5 microns to enhance bioavailability in oral suspensions or low-dose solid tablets.
Standard MOQs for commercial Deflazacort API start at 1 kg for R&D/clinical evaluation phases up to multi-hundred kilogram commercial shipments. Standard lead time is 2-4 weeks for stocked batches, or 6-8 weeks for customized micronized batches.
Every batch undergoes dual-testing: in-house cGMP lab analysis via high-resolution HPLC-MS and GC-HS, followed by independent COA verification. We utilize validated packaging (aluminum foil moisture-barrier liners under nitrogen flush) to maintain stability in accordance with ICH Zone IVb storage conditions.
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