Carfilzomib (CAS 868540-17-4) is a second-generation, irreversible proteasome inhibitor. It’s primarily used for relapsed/refractory multiple myeloma and mantle cell lymphoma – especially in patients who no longer respond to bortezomib. Clinical data show that regimens containing Carfilzomib (like Kd or KRd) significantly improve progression-free survival and overall response rates.
At Cosperpharm, we produce Carfilzomib API under strict GMP with HPLC purity ≥99.5%. Our manufacturing setup includes 150+ reactors (20L–5000L) and 6 D-grade clean lines, supporting everything from R&D grams to commercial tons. We also hold a valid pharmaceutical export license – so when you buy Carfilzomib from us, you get full documentation and hassle-free customs clearance. No middlemen, no compliance surprises.
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Parameter |
Specification |
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CAS Number |
868540-17-4 |
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Molecular Formula |
C₄₀H₅₇N₅O₇ |
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Molecular Weight |
719.91 g/mol |
|
Purity (HPLC) |
≥99.5% |
|
Any single impurity |
≤0.10% |
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Total impurities |
≤0.50% |
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Particle Size (D90) |
≤20 µm (customizable) |
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Appearance |
White to off-white crystalline powder |
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Storage |
2-8°C, protected from light |
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Packaging |
1g, 5g, 10g, 50g, 100g (customizable) |
The above specifications are a comprehensive reference version based on general standards of EMA (Europe) and FDA (USA).
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Advantage |
Details |
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Production Strength |
GMP-certified facility spanning 100+ mu with 3 multi-purpose workshops, 6 D-grade clean zone production lines, and 150+ reactors (20L–5000L), supporting high/low temperature, anaerobic, and hydrogenation conditions; production from kg to metric ton scale |
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Fast Delivery |
Stocked R&D samples ship within one week; commercial orders: one to two months after payment. Express (DHL/FedEx) or air/sea freight available |
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Global Partners |
Trusted by 30+ pharmaceutical companies in USA, Europe, India, Brazil, and Southeast Asia; long-term cooperation with generic drug manufacturers and CROs |
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Licensed Exporter |
Valid drug import/export license – no compliance delays. We provide COA, stability data and export documents |
`Relapsed or Refractory Multiple Myeloma (RRMM): As monotherapy or in combination with dexamethasone (Kd) or lenalidomide + dexamethasone (KRd) for patients who have received 1–3 prior lines of therapy.
`Mantle Cell Lymphoma (MCL): Approved in several countries for relapsed patients, though multiple myeloma remains its core indication.
`Combination Therapies: With daratumumab + dexamethasone (DKd) or isatuximab + dexamethasone (IKd) for RRMM patients with 1–3 prior lines of therapy.
FDA Approval Milestones: Carfilzomib was first approved by the FDA in July 2012 for RRMM patients who had received at least two prior therapies, including bortezomib and an immunomodulatory agent. In 2016, the FDA expanded approval to include combination with dexamethasone or lenalidomide + dexamethasone for patients with 1–3 prior lines of therapy, and also converted single-agent accelerated approval to full approval. In 2018, the FDA added positive overall survival data from the phase 3 ASPIRE trial to the label.
`ASPIRE trial (phase 3): KRd regimen prolonged progression-free survival (PFS) to 26.3 months vs 17.6 months with Rd alone, and reduced the risk of death by 21%.
`ENDEAVOR trial (phase 3): Kd regimen reduced the risk of progression by 47% compared with bortezomib + dexamethasone (Vd), with median PFS of 18.7 months vs 9.4 months (HR 0.53; P<0.0001). Carfilzomib + dexamethasone extended overall survival by 7.6 months compared with bortezomib + dexamethasone (47.6 vs 40 months).
`EMN20 trial (phase 3, 2025): Weekly KRd regimen showed MRD-negativity rate of 60% vs 0% in the control group at 2 years (P<0.0001), with 24-month PFS rate of 83% vs 49% (HR 0.24; P=0.00084).
`Global Market Presence: Global Carfilzomib API market was valued at USD 215.4 million in 2024 and is projected to reach USD 412.9 million by 2032, at a CAGR of 7.8%. The drug has been included in China’s National Reimbursement Drug List, with hospital sales in China reaching RMB 152 million in H1 2025.
`Guideline Recommendations: Carfilzomib is recommended by multiple international and domestic guidelines for the treatment of multiple myeloma, including the NCCN Guidelines and Chinese multiple myeloma diagnosis and treatment guidelines
`High purity & low impurities – suitable for injectable formulations
`Customizable particle size – optimize your formulation dissolution profile
`Valid export license – Cosperpharm is an authorized Carfilzomib exporter
`Irreversible binding to 20S proteasome – overcomes bortezomib resistance
`High selectivity with low neurotoxicity – better patient tolerability
`Rapid onset – first-dose proteasome inhibition detectable within 24 hours
`Superior efficacy – ORR up to 87% with KRd regimen
Cosperpharm specializes in the production of Carfilzomib API in state-of-the-art GMP-compliant multi-purpose workshops, equipped with six Class D clean zone production lines. Our facility features more than 150 reactors ranging from 20L to 5000L, capable of supporting high/low-temperature reactions, anaerobic processes and hydrogenation. This allows us to flexibly supply Carfilzomib API from kilogram scale up to metric tonnage.
Every batch is subject to strict quality control testing, including HPLC, GC, LC-MS, residual solvent analysis in accordance with ICH Q3C, heavy metal detection and genotoxic impurity testing. We ensure complete traceability throughout the entire production chain, from raw materials to the finished API.
Q1: What is your MOQ for Carfilzomib API?
A: For R&D samples: 1g. For commercial orders: 10g–100g. Larger volumes can be provided upon request.
Q2: What is your normal lead time?
A: In-stock R&D samples: within 1 week. Bulk orders: 1–2 months after payment confirmation.
Q3: To which countries do you export?
A: We have exported to the USA, Canada, Germany, UK, Spain, India, Brazil, South Korea, Japan, and other regions. We are familiar with local customs clearance and regulatory requirements.
Q4: Can you support third-party testing or factory audits?
A: Yes. We welcome on-site audits and inspections by SGS, BV or other authorized institutions. Third-party testing can be arranged at the buyer’s expense.
Q5: What certifications do you have?
A: We hold GMP certification, ISO 9001:2015 certificate, pharmaceutical import and export license, as well as COA for each batch.
Q6: Is Carfilzomib API stable for long-term storage?
A: Yes. When stored at 2–8°C in a tightly sealed, light-proof container, Carfilzomib API is stable for 24 months. Accelerated and long-term stability data are available upon request.
Q7: Can you provide cold chain transportation?
A: Yes. We support 2–8°C cold chain delivery through professional couriers such as DHL Cold Chain and FedEx Custom Critical. Temperature loggers can be provided if required.
Looking to source high-quality Carfilzomib API? Get in touch with Cosperpharm now to request your sample or receive a competitive quotation. We are dedicated to serving as your reliable long-term China-based supplier for Carfilzomib.
Address
No. 2 Yangguang 3rd Road, Duodao Chemical Cycle Industrial Park, Jingmen City, Hubei Province, China
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