Explore our standard-compliant high-purity APIs, custom synthetic peptides, and critical chemical intermediates produced under strict cGMP environments.
Comprehensive chemical profile, polymorphic stability analysis, and quality standards engineered for complex finished dosage form (FDF) development.
Lenalidomide (CAS Registry Number: 191732-72-6; Chemical Formula: C13H13N3O3) represents a cornerstone therapeutic agent in immunomodulatory drug (IMiD) discovery. Structurally derived from thalidomide through targeted chemical modifications—specifically the removal of a carbonyl group from the phthaloyl ring and the introduction of an amino group at position 4 of the benzene ring—Lenalidomide exhibits significantly heightened potency alongside an altered neuro-toxicity profile.
The molecular mechanism relies on selective binding to Cereblon (CRBN), a primary component of the CRL4CRBN E3 ubiquitin ligase complex. Upon binding, Lenalidomide induces a conformational alteration on the surface of CRBN, enabling the recruitment, ubiquitination, and subsequent proteasomal degradation of key zinc-finger transcription factors: IKZF1 (Ikaros) and IKZF3 (Aiolos). This targeted protein degradation leads to direct cytotoxic effects in malignant B-cell lineages and immune-mediated anti-tumor responses through T-cell and Natural Killer (NK) cell activation.
Gentolex's proprietary synthesis pathway controls genotoxic impurities (including alkylating intermediate compounds and nitro-derivatives) well below the ICH M7 Threshold of Toxicological Concern (TTC) limit (< 1.5 µg/day). Single unspecified impurities are routinely limited to < 0.05% via automated crystallization techniques.
| Analytical Parameter | Standard Specification | Gentolex High-Purity Grade |
|---|---|---|
| Chemical Assay (HPLC) | 98.0% – 102.0% | ≥ 99.7% (Anhydrous Basis) |
| Enantiomeric Purity (Chiral HPLC) | ≥ 99.0% (S-Isomer) | ≥ 99.9% (Single Enantiomer) |
| Polymorphic Form | Form B (Hemihydrate) / Form I | Pure Form B (XRPD Confirmed) |
| Heavy Metals | ≤ 20 ppm | ≤ 5 ppm (ICP-MS Verified) |
| Residual Solvents (ICH Q3C) | Complies with limits | DMF < 100 ppm, Ethanol < 500 ppm |
| Particle Size Distribution | d90 < 100 µm | Customizable (Micronized d90 < 10 µm) |
Navigating patent expiration horizons, supply disruption risks, and high-demand oncology generic transitions with scalable industrial manufacturing.
As key reference drugs face patent cliff transitions in multiple global territories, pharmaceutical developers require secured API sources with non-infringing process patents. Gentolex offers robust freedom-to-operate (FTO) synthesis pathways designed for rapid market insertion without IP conflict.
Recent global events highlighted severe vulnerabilities in key starting material (KSM) sourcing. Gentolex mitigates geopolitical and transport risks by maintaining dual-source upstream chemical inputs and backward integration for critical intermediates.
Hematological malignancies place enormous financial burdens on healthcare systems worldwide. By optimizing yield efficiency in large-scale reactors, Gentolex drastically lowers manufacturing overheads, facilitating cost-effective generic Lenalidomide availability globally.
Our 250,000 square meter standardized plant engineered for high-containment APIs, continuous flow reactions, and zero-defect quality control.
Gentolex operates an extensive industrial infrastructure spanning 250,000 square meters built strictly in accordance with international cGMP standards (US FDA, EU GMP, PIC/S compliant). Our dedicated cytotoxic and high-potency active pharmaceutical ingredient (HPAPI) isolation cleanrooms feature OEB-4 / OEB-5 containment levels, ensuring complete safety and cross-contamination prevention during Lenalidomide manufacturing.
Through continuous micro-reactor processing and automated crystallization technology, we maintain total control over solid-state polymorphic transitions. This ensures that every batch delivers identical crystal habit, dissolution profiles, and chemical stability required for oral capsule and tablet formulations.
Direct technical assistance, region-specific dossier support, and physical representative hubs facilitating fast regional market registration.
We provide comprehensive US DMF Type II, EU CEP/COS documentation, and eCTD formatted dossiers. Analytical validation reports according to ICH Q2(R1) guidelines are fully accessible for customer licensing and regulatory audit readiness.
To deliver seamless technical communication and swift supply logistics, Gentolex has established direct representative footprints in key emerging markets including Mexico and South Africa, alongside global shipping routes.
Beyond API synthesis, Gentolex specializes in Finished Dosage Form (FDF) license-out agreements, technical transfer consultation, laboratory setup, and customized contract development and manufacturing organization (CDMO) services.
From first-line multiple myeloma regimens to targeted hematological therapies, Lenalidomide provides targeted efficacy across broad clinical indications.
Lenalidomide serves as the backbone therapy for newly diagnosed multiple myeloma (both transplant-eligible and non-transplant candidates) in combination with dexamethasone, or as triplet therapy with proteasome inhibitors (e.g., RVd regimen) and anti-CD38 monoclonal antibodies.
Indicated for patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality [del(5q)], inducing transfusion independence and cytogenetic response.
Utilized in relapsed or refractory Mantle Cell Lymphoma (MCL) and previously treated Follicular Lymphoma or Marginal Zone Lymphoma (R² regimen with rituximab), offering oral therapeutic options for indolent and aggressive disease forms.
Pioneering molecular targeted degradation through advanced Cereblon E3 ligase research and automated synthesis engineering.
Standardization of high-density crystal habits to optimize powder flowability for direct compression and automated capsule filling machines. Implementation of air-jet micronization tailored for specific dissolution kinetics.
Replacing batch hydrogenation reactors with continuous flow micro-channel synthesis systems. This transition increases reaction yield by 14%, eliminates thermal runaway hazards, and strictly isolates dangerous intermediates.
Leveraging Lenalidomide derivative core structures as functional E3 ligase recruiting ligands for custom Proteolysis Targeting Chimeras (PROTACs), facilitating selective degradation of previously undruggable oncogenic targets.
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.
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View DetailsDetailed answers regarding Lenalidomide API sourcing, solid-state specifications, DMF support, and cGMP compliance.
Gentolex primarily manufactures and supplies pure Polymorphic Form B (Hemihydrate), as well as Form I upon commercial request. Polymorphic integrity is vital for oral drug products because different crystal forms exhibit distinct aqueous solubility, bioavailability, and mechanical compressibility profiles. Form B demonstrates optimal thermodynamic stability under standard humidity and temperature conditions, eliminating risk of spontaneous polymorphic transformation during storage or direct compression tableting.
Our process chemistry team has designed a clean reaction cascade that minimizes potential genotoxic alkylating intermediates. Every batch undergoes rigorous testing using liquid chromatography-tandem mass spectrometry (LC-MS/MS) capable of detecting trace impurities down to sub-ppm levels. Genotoxic impurities are guaranteed to meet the stringent requirements of ICH M7 limits (< 1.5 µg daily intake baseline), safeguarding regulatory dossier approvals.
Yes, complete US DMF Type II documentation is active, and EU CEP filings are fully supported along with regional registration packages for Latin America (including Mexico), Africa (including South Africa), and Asia-Pacific. We provide Letters of Authorization (LOA) to permit regulatory agencies to review our DMF in support of your Finished Dosage Form (FDF) Abbreviated New Drug Applications (ANDA).
Absolutely. We offer tailored particle sizing options including micronized grades (d90 < 10 µm) and specific coarse distributions via specialized fluid energy jet milling. Customized PSD parameters help generic formulation scientists achieve rapid dissolution rates matching reference listed drugs (RLDs) without changing formulation excipients.
Gentolex provides end-to-end support for pharmaceutical partners seeking finished drug licensing. Our technical teams deliver ready-to-fill capsule formulations, analytical transfer protocols, bioequivalence (BE) study batch support, and complete manufacturing process setup consultation to accelerate your commercial launch timing.
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