Pomalidomide, known chemically as (RS)-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline-1,3-dione, with CAS number 19171-19-8, stands as a pivotal immunomodulatory agent in modern oncology. As a seasoned B2B supplier of pharmaceutical APIs like pomalidomide, we've witnessed its evolution from a thalidomide derivative to a cornerstone in multiple myeloma treatment protocols. First approved by the FDA in 2013 under the brand name Pomalyst, pomalidomide has redefined refractory multiple myeloma therapy, offering superior efficacy over predecessors like lenalidomide in heavily pretreated patients.

In the pharmaceutical landscape of 2026, demand for high-purity pomalidomide API surges due to expanding clinical applications. This small-molecule drug, with a molecular formula of C13H11ClN4O4 and molecular weight of 273.70 g/mol, exhibits potent anti-angiogenic, anti-proliferative, and immunomodulatory properties. It binds to cereblon (CRBN), facilitating the ubiquitination and degradation of transcription factors Ikaros (IKZF1) and Aiolos (IKZF3), which downregulates pro-inflammatory cytokines and enhances T-cell and NK-cell activity. For corporate purchasing managers in the USA, sourcing reliable pomalidomide isn't just about availability—it's about ensuring 99.5%+ HPLC purity, compliance with USP/EP standards, and scalable supply from grams to metric tons.

Our deep dive into pomalidomide reveals its mechanism: Unlike thalidomide, pomalidomide features a chlorine substitution enhancing potency while minimizing sedative side effects. Clinical trials, such as MM-003 (NEJM 2014), demonstrated a 31% overall response rate in patients refractory to bortezomib and lenalidomide, with median progression-free survival of 4 months. By 2026, ongoing studies explore pomalidomide combinations with daratumumab and CAR-T therapies, projecting a global market exceeding $2.5 billion annually (Grand View Research, 2025 forecast). As your pomalidomide supplier, Global Technology Co., Ltd bridges this gap with GMP/DMF-certified production, leveraging China's robust supply chain for unbeatable ROI.

Technically, pomalidomide powder appears as a white to off-white crystalline solid, soluble in DMSO (>50 mg/mL) but sparingly in water (0.1 mg/mL). Stability under ICH guidelines (Q1A) ensures 24+ months shelf life when stored at 2-8°C. For OEM/ODM clients, we customize particle size (D90 <10μm via jet milling), polymorphic forms (Form A predominant), and residual solvents (<5000ppm total, per USP <467>). Pain points like batch-to-batch variability plague Western buyers—our COA guarantees <0.5% single impurities, backed by third-party testing from SGS/Intertek.

Historically, pomalidomide's development stemmed from thalidomide's tragedy-rebirth narrative. Revlimid (lenalidomide) paved the way, but resistance necessitated pomalidomide's third-generation profile. In research chemicals, it's indispensable for preclinical models of myeloma, lymphoma, and even COVID-19 immunomodulation studies (pre-2026 retrospectives). USA importers face FDA 503B/503A scrutiny; our DMF filings streamline your IND/NDA processes. Economically, our factory-direct model slashes costs by 37% vs. Indian/EU competitors, with DDP shipping to major ports like Los Angeles or New York in 7-14 days.

Beyond myeloma, emerging uses include systemic lupus erythematosus (SLE) and graft-versus-host disease (GVHD), per Phase II trials. Pharmacokinetics: Oral bioavailability ~73%, Tmax 2-3h, half-life 9-11h, metabolized via CYP1A2/CYP3A4. Dosage forms derive from our API: 1mg, 2mg, 4mg capsules. As API wholesalers, we serve CROs, CDMOs, and generic majors, ensuring traceability via ERP systems and blockchain pilots for 2026 compliance.

Quality assurance is non-negotiable. Our partnered GMP facilities (Zhengzhou-based) employ HPLC-MS, XRPD, and DSC for comprehensive characterization. Microbial limits: TAMC <100 CFU/g, TYMC <10 CFU/g, per Ph. Eur. 2.6.12. Heavy metals <10ppm (ICP-MS). For your operations, this means zero recalls, seamless integration into tablet/capsule lines. Competitors falter on service—our 24/7 support, flexible MOQs (1g for R&D), and ODM formulations (e.g., enteric-coated pomalidomide) differentiate us.

In summary (word count: ~850 for intro), pomalidomide represents reliability in uncertainty. Whether scaling production or fueling R&D, partner with Global Technology for pomalidomide that delivers results. Ready to optimize your supply chain? Continue reading or request a sample today.

Your Top Challenges Sourcing Pomalidomide API in 2026

As a purchasing manager, you know the stakes: delayed trials cost $100K+/week. Here's what USA buyers face:

• High Prices: EU/India suppliers charge $15,000-$20,000/kg, eroding your ROI amid inflation.
• Low Quality & Variability: 95-97% purity leads to failed stability tests; 28% of imports rejected by FDA (2025 data).
• Skyrocketing Shipping Costs: Post-2024 disruptions, DHL/FedEx fees hit $2,500/kg for hazmat APIs.
• Supply Chain Disruptions: Single-source dependency causes 3-6 month delays during peaks.
• Regulatory Hurdles: Missing DMF/GMP docs stall your 503B registrations.
• Poor Service: No customization, rigid MOQs alienate agile buyers.

These issues compound: A single bad batch can halt production lines costing $500K/day. What's your next step? Discover our solutions below.

Global Technology's Pomalidomide: Powerful Factory Advantages

Overcome these with our USPs: Factory-direct, GMP-certified pomalidomide at scale.

• Powerful Factory Capacity: 50MT/year output; grams to tons.
• Quality Assurance: 99.7% purity, full COA/DMF.
• OEM/ODM Design: Custom polymorphs, formulations.
• High-Speed Delivery: 7-day air to USA, DDP terms.
• Cost Leadership: 37% savings – $9,500/kg bulk.
• Flexible Service: 24/7, multi-payment (T/T, LC, PayPal).

Pomalidomide API Technical Specifications

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Real-World Applications & Case Studies

Case Study 1: USA CDMO scaled pomalidomide combo trials; our API reduced costs by 32%, zero deviations in 5 tons supplied.

Case Study 2: Research institute in California: 99.8% purity enabled breakthrough IKZF degradation studies.

Micro-CTA: Schedule a demo batch? Contact us now.

Proof of Excellence: Factory, Clients & Certifications

Trusted by 200+ Global Pharma Leaders

"Switched to Global for pomalidomide—45% cost down, flawless quality. Best decision for our myeloma line." – Ops Mgr, USA CDMO

Certifications: GMP, DMF (filed with FDA), ISO 9001, CEP, RoHS-compliant processes. Full audit reports available. Privacy policy: View here.

FAQ: Your Pomalidomide Procurement Questions Answered

Secure Your Pomalidomide Supply Now – Limited Q1 2026 Stock!

Limited-time: Free 5g sample + 5% discount on first 10kg order. Risk-free: Money-back if purity <99.5%.

Global Technology Co., Ltd | No. 14, 863 Park, Zhongyuan District, Zhengzhou City, Henan Province, China. Tel: +86 19943830844

Real User Reviews: Pomalidomide from Global Technology

Mike R., Purchasing Director, PharmaCorp USA

"Outstanding pomalidomide quality—99.8% pure, delivered in 8 days. Saved us 40% vs. previous supplier. Highly recommend!"

★★★★★

Dr. Sarah L., R&D Manager, BioLabs Inc., California

"Perfect for our myeloma research. Custom particle size spot-on. Fastest API supplier ever—will reorder tons."

★★★★★

Tom K., Supply Chain Lead, Generic Pharma USA

"GMP docs facilitated FDA filing. No quality issues in 2MT. Service beats competitors hands-down."

★★★★★

Elena M., Operations Mgr, East Coast CDMO

"Free sample convinced us. Bulk order seamless, 35% cheaper with same purity. True partner!"

★★★★★

About the Author

Dr. Li Wei, PhD

Seasoned Pharmaceutical Chemist & Export Director at Global Technology Co., Ltd. With 25+ years in API synthesis, Dr. Wei led pomalidomide scale-up projects for FDA-approved generics. Contributor to Journal of Medicinal Chemistry; former adjunct at Zhengzhou University Lab. Passionate about bridging China-USA supply chains for oncology APIs.