Lenalidomide API

Lenalidomide API
Details:
Lenalidomide API (CAS 191732-72-6) is a core second‑generation immunomodulatory antineoplastic API in global clinical practice. It combines four core activities: direct tumor cell killing, immune activation, anti‑angiogenesis, and drug resistance reversal.
  • CAS Number 191732-72-6
  • Formula C13H13N3O3
  • Storage Store at -20℃
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Description
Technical Parameters

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Lenalidomide API (CAS 191732-72-6) is a core second‑generation immunomodulatory antineoplastic API in global clinical practice. It combines four core activities: direct tumor cell killing, immune activation, anti‑angiogenesis, and drug resistance reversal. It is a cornerstone raw material for the treatment of hematologic malignancies such as multiple myeloma, myelodysplastic syndrome, and lymphoma, and also a key synergistic component in combination regimens for solid tumors, holding an pivotal position in the global antineoplastic pharmaceutical market.

 

Technical Specifications

 

 

Product Name

Lenalidomide API

Synonyms

CAS 191732-72-6, Lenalidomide Powder, Lenalidomide Raw Material, Lenalidomide API 191732-72-6

Characteristics

Off-white to light yellow crystalline powder

CAS Number

191732-72-6

Assay

≥99.5% (HPLC, Subject to the COA)

Formula

C13H13N3O3

Package

Technical Package

Storage

Store at -20℃

Structure

product-428-358

 

Lenalidomide API acts through the core mechanism of molecular glue targeting. It specifically binds to the Cereblon (CRBN) E3 ubiquitin ligase complex, precisely degrades oncogenic transcription factors such as Ikaros and Aiolos, blocks tumor cell proliferation signals, and induces apoptosis. Meanwhile, it activates T‑cell and NK‑cell activity, enhances immune surveillance, inhibits tumor angiogenesis, and blocks tumor progression through multiple pathways. Authoritative data confirm that Lenalidomide Powder combined with dexamethasone for relapsed and refractory multiple myeloma achieves an objective response rate of 60.6%. Median progression‑free survival extends to 13.9 months, and overall survival exceeds 3 years, which is far superior to conventional chemotherapy. Its neurotoxicity is significantly lower than thalidomide, making it safer for long‑term maintenance therapy.

 

 
 
Product Features

Lenalidomide API1

01.

Lenalidomide Raw Material is an off‑white to light yellow crystalline powder. It is odorless, bitter in taste with uniform crystal form, featuring excellent flowability. As a highly potent antineoplastic API, our product has a main component content ≥ 99%, with maximum single impurity ≤ 0.10%. Key indicators including residual solvents, heavy metals (Pb, As, Cd, Hg, etc.), elemental impurities, bacterial endotoxins, and microbial limits all exceed international requirements. Our partner factories adopt green synthesis processes, eliminating traditional toxic halogenated reagents. Through one‑pot catalytic coupling and efficient reductive cyclization technologies, the overall yield is increased to above 75%, meeting global environmental standards for pharmaceutical production.

02.

Lenalidomide API is highly targeted and fast‑acting. After oral administration, peak plasma concentration is reached within 0.5-1.5 hours, with a half‑life of 3 hours. Once‑daily dosing maintains effective plasma concentrations. In terms of immunomodulation and resistance reversal, Lenalidomide API reduces pro‑inflammatory factors such as TNF‑α and IL‑6, enhances immune cell cytotoxicity. When combined with chemotherapy, targeted agents, or immune checkpoint inhibitors, it reverses tumor resistance by 4-8 folds, improves chemotherapy efficacy by more than 30%, and reduces cardiac, gastrointestinal, and other chemotherapy‑related toxicities. Lenalidomide API shows no significant nephrotoxicity or hepatotoxicity. Grade 3/4 hematologic adverse reactions are controllable and rapidly relieved by dose adjustment. It does not cause alopecia or severe vomiting typical of conventional chemotherapy, resulting in high patient tolerance and suitability for long‑term use in elderly and frail cancer patients.

Lenalidomide API2

 

Full‑Cycle Quality Control and Stable Quality
 

 

Full‑Process Traceability Control

We cooperate with leading certified partner factories to implement full‑chain closed‑loop control for Lenalidomide API 191732-72-6 from starting materials to finished goods delivery. Starting materials are sourced from qualified suppliers, with a COA included for each batch. Processes including synthesis, purification, drying, milling, and packaging are fully conducted in GMP cleanrooms with real‑time process parameter recording. Each batch is assigned a unique batch number, with complete retention of test data, enabling full traceability, verifiability, and re‑testing throughout production, inspection, storage, and transportation. Each shipment of Lenalidomide Raw Material is accompanied by a full compliant Certificate of Analysis covering content, related substances, moisture, residue on ignition, heavy metals, residual solvents, microbial limits, crystal form identification, and other items, with authentic and verifiable data to support domestic and international registration filings.

Strict Standard and Compliance Assurance

Lenalidomide API strictly complies with ICH Q7, USP, EP, JP, and CP pharmacopeial standards, performing comprehensive tests including HPLC assay, GC residual solvent analysis, ICP‑MS elemental impurity analysis, XRD crystal form identification, and microbial limit testing. Key specifications exceed international pharmacopeial standards. The product features a complete global registration support system, providing full documentation including DMF files, technical packages, stability data, and genotoxic impurity assessment reports. This supports customers in successfully passing reviews by regulatory authorities in Europe, the United States, Japan, South Korea, Southeast Asia, the Middle East, and other regions, enabling efficient commercialization of finished formulations.

Continuous Quality System Optimization

Supported by ongoing technological upgrades at partner factories, we continuously optimize the synthesis and purification processes of Lenalidomide Powder to improve purity, stability, production efficiency, and cost‑effectiveness. A robust system of deviation handling, change control, and annual quality review is established, with regular benchmarking and upgrading to ensure uniform and stable quality in every batch of Lenalidomide API, providing customers with long‑term reliable raw material supply.

Application Scenarios

 

Application

Hematologic Malignancies

Lenalidomide API is a core raw material for first‑line, second‑line, and maintenance therapy of multiple myeloma. Combination with dexamethasone is a standard regimen for relapsed and refractory multiple myeloma; it is also used for maintenance after autologous stem cell transplantation, extending progression‑free survival by more than two times and significantly reducing recurrence risk. Furthermore, Lenalidomide API is indicated for mantle cell lymphoma, follicular lymphoma, and non‑germinal center diffuse large B‑cell lymphoma. Combined with rituximab in the R2 regimen, the 3‑year progression‑free survival rate reaches 77%, with a lower adverse reaction rate than chemotherapy, providing a safer option for lymphoma patients.

Solid Tumor Adjuvant Therapy

The product modulates the solid tumor microenvironment and improves tumor perfusion. When combined with cisplatin, paclitaxel, anthracyclines, or PD‑1/PD‑L1 inhibitors, it increases tumor inhibition rate by more than 40% and reverses multidrug resistance. It is suitable for sensitization and toxicity reduction in solid tumors including lung, liver, breast, and colorectal cancers, which is conducive to expanding the application of combination antineoplastic regimens.

Innovative Drug R&D and Standard Reference

Lenalidomide Powder can be used as a reference standard and working standard for pharmacological and toxicological studies, pharmacokinetic testing, formulation screening, and quality standard establishment. It also supports the R&D of Lenalidomide derivatives, prodrugs, nanoparticles, oral sustained‑release preparations, and other innovative drugs, facilitating breakthroughs in oncology R&D and meeting the needs of universities, research institutions, and pharmaceutical companies.

 

Packaging and Transportation

 

Lenalidomide Powder is vacuum‑sealed in pharmaceutical‑grade aluminum foil bags with desiccant and light protection, housed in moisture‑resistant fiber drums or plastic drums. The packaging provides light resistance, moisture protection, oxidation resistance, and physical durability to ensure stable quality during storage and shipment. Standard packaging: 1 kg, 5 kg, 10 kg, 25 kg. Customized packaging is also available with adjustable specifications and materials upon request. Logistics strictly follows pharmaceutical and dangerous goods transportation standards with constant‑temperature and light‑protected shipment throughout. Domestic distribution is handled by professional pharmaceutical logistics teams; international transport complies with UN regulations, offering air freight, sea freight, and international express with full track‑and‑trace for safe and on‑time delivery. We possess complete export qualifications, customs documentation, and freight forwarding resources to enable efficient and compliant customs clearance for global customers.

Lenalidomide Powder

 

 
 
Our Advantages

Stable Capacity and In‑Stock Supply

We have long‑term supply agreements with multiple GMP, FDA, and CEP certified partner factories, enabling rapid response to urgent and bulk orders. We support R&D pilot trials and large‑volume procurement, with long‑term contract supply to ensure supply chain stability.

High‑Standard Quality Assurance

Products originate from certified factories with full‑process strict quality inspection. Lenalidomide API purity is stably ≥ 99.0%. Risks including genotoxicity and heavy metals are tightly controlled, providing core assurance for formulation safety and R&D success and helping customers develop high‑quality antineoplastic preparations.

Mature Export and Global Service

With more than 10 years of global export experience and a complete system of customs declaration, inspection, logistics, and documentation, we can supply Lenalidomide API (CAS 191732-72-6) to over 100 countries and regions including Europe, the United States, Japan, South Korea, Southeast Asia, the Middle East, and South America. We also provide multilingual support that ensures stable replenishment, .

Customization and Technical Support

We provide customized services including adjustable particle size, drying method, and packaging specifications. We assist customers in solving technical challenges in formulation R&D, production, and registration.

Comprehensive After‑Sales System

We have established a 7×12 hour rapid response after‑sales system to promptly address order, logistics, quality, and technical issues, ensuring a worry‑free experience from inquiry, procurement, and receipt to use, providing customers with one‑stop procurement services.

 

FAQ

 

Q1: Can you provide Lenalidomide Free Sample for R&D testing?

A: Free samples are available for qualified potential customers, suitable for quality testing, formulation screening, method validation, and preliminary R&D evaluation. Sample sizes meet pilot requirements; freight is borne by the customer.

Q2: What is the minimum order quantity?

A: The MOQ for R&D pilot trials is 10 g. For pilot and commercial production, we support large‑scale Lenalidomide procurement with flexible MOQ to match different R&D and production stages.

Q3: Can you provide complete registration documents?

A: Full sets of compliant technical documents are available, including COA, HNMR, LC‑MS, HPLC assay chromatograms, residual solvents, heavy metals, microbial limits, stability data, DMF files, etc., supporting domestic and international pharmaceutical registration.

Q4: Does Lenalidomide API meet international pharmacopeial standards?

A: Lenalidomide API (CAS 191732-72-6) is manufactured in strict compliance with ICH Q7, CP, USP, EP, and JP standards at GMP/FDA/CEP certified partner factories, with quality fully aligned with international requirements.

Q5: What is the delivery lead time?

A: In‑stock orders are shipped within 1-3 working days after payment. Bulk customized orders have a lead time of 7-15 working days, with priority scheduling available per customer plan.

 

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