Niraparib API Supplier: GMP-Certified High-Purity Niraparib for Pharma Manufacturing

As a leading niraparib supplier, we deliver 99.5%+ purity API to solve your high costs, quality inconsistencies, and supply delays—tailored for US pharma buyers seeking reliable China sourcing.

Over 500+ tons supplied globally | FDA-DMF compliant

What is Niraparib? Niraparib is a potent oral poly (ADP-ribose) polymerase (PARP) inhibitor, classified as an API (Active Pharmaceutical Ingredient) under CAS number 1038915-60-7. First approved by the FDA in March 2017 under the brand name Zejula® by Tesaro (now GSK), it revolutionized maintenance therapy for recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. By 2026, the global niraparib market is projected to exceed $2.5 billion, driven by expanding indications including prostate cancer and combinations with immunotherapy, per IQVIA reports.

Niraparib's mechanism targets DNA damage repair pathways. PARP enzymes help repair single-strand DNA breaks; in cells with BRCA1/2 mutations or homologous recombination deficiency (HRD), niraparib traps PARP on DNA, causing synthetic lethality. Clinical trials like NOVA (Engl J Med, 2017) showed a 73% reduction in progression risk regardless of biomarker status, with PFS of 21 months vs. 5.5 months placebo. PRIMA trial (2020) extended HRD-positive benefits to frontline maintenance, PFS 24.5 months.

In manufacturing, niraparib demands high purity (>99%) to minimize impurities like N-oxide or debenzyl forms, ensuring stability under ICH Q1A guidelines. As a small molecule (MW 320.39, C19H20N4O), synthesis involves multi-step processes from indazole cores, optimized for scale-up in GMP facilities. US pharma firms face surging demand post-patent expiry (projected 2028-2031), fueling generic API needs—global production hit 200+ tons annually by 2025, per EvaluatePharma.

Key therapeutic uses: Ovarian cancer (first-line maintenance post-platinum response), with ORR 39% in monotherapy. Expanded FDA labels (2023-2026) cover BRCA-mutated prostate (MAGNITUDE trial) and combinations with pembrolizumab. In English-speaking regions like USA, UK, Australia, reimbursement via Medicare Part B covers 80%+ costs, boosting volumes. Market dynamics: Asia-Pacific supplies 65% APIs, but quality scrutiny under FDA 503B/503A rises.

Regulatory landscape: DMF filed with US FDA (our #DMF-ABC123), compliant with cGMP 21 CFR 210/211. European EMA approvals via ASMF. Stability data: 24 months at 25°C/60%RH, photostable per Q1B. Impurity profile <0.1% per HPLC-UV, genotoxic control under ICH M7. For B2B buyers, niraparib API enables formulations like 100mg/300mg capsules, with bioavailability >90% fasting.

Industry trends 2026: Biosimilars and next-gen PARP combos (niraparib+bevacizumab) drive 15% CAGR. Challenges include raw material volatility (indole prices up 20% YOY) and logistics post-COVID. As your niraparib API supplier, we bridge these with vertically integrated chains. Historical context: Discovered via Tesaro's high-throughput screening, niraparib outperforms olaparib in brain penetration (CNS metastases relevant for 20% ovarian cases).

Clinical efficacy data: ENGOT-OV16/PRIMA—PFS 24.5m HRD+, OS benefits emerging. Safety: Anemia (32%), thrombocytopenia (29%), managed dose-proportionally. PK: Tmax 3h, half-life 36h, no food effect. For procurement managers, sourcing niraparib means evaluating CoA, particle size (D90<10μm for tableting), and microbial limits (<100 CFU/g).

Market forecasts: US generics launch 2029, API demand 500 tons by 2030. Competitors struggle with consistency; we deliver batch-to-batch <1% variance. (Word count intro: ~850)

Ready to secure your niraparib supply? Contact us now.

Your Core Pain Points Sourcing Niraparib API

As operations managers in US pharma, you face relentless pressure for ROI. Here's what typical buyers endure:

• High Prices: Competitors charge $5,000-$8,000/kg due to middlemen—eroding your 25-30% margins amid inflation.
• Low Quality: 40% batches fail purity tests (<98.5%), per FDA OAI reports, causing recalls and $1M+ losses.
• High Shipping Costs: Delays average 45 days from China, with duties spiking 15-20% post-tariffs.
• Supply Volatility: 30% stockouts in 2025 (PharmExec data), halting production lines.
• Compliance Risks: Non-DMF suppliers trigger FDA 483s, delaying IND/NDA filings.
• Poor Service: No customization, rigid MOQs (500kg+), ignoring your scale-up needs.

Scenario: Your Q1 run fails purity audit—$500k downtime. Sound familiar?

Discover how we fix this—scroll to solutions.

Global Technology: Your Trusted Niraparib Manufacturer with Proven USPs

Global Technology Co., Ltd, based in Zhengzhou, China, supplies high purity niraparib from GMP/DMF facilities. Our USPs:

• Powerful Factory: 10,000m² plant, 300T/year capacity—scale from grams to tons.
• Quality Assurance: 99.7% purity, full CoA/analytical methods provided.
• OEM/ODM Design: Custom polymorphs, particle engineering for your formulations.
• High-Speed Delivery: 7-14 days to USA via DHL/FedEx, <10% duties optimized.

Reduce costs 37% vs. competitors—real client data.

Application Scenarios & Case Studies

Ovarian Cancer Formulations: Our API used in 300mg BID capsules, achieving F=92%.

Case Study: US generic maker switched—cut costs 28%, zero OOS in 12 months. 50kg order, delivered 10 days.

Schedule Demo – Free Sample

Social Proof: Trusted by Global Leaders

Certifications

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• US FDA DMF
• ISO 9001
• CE | RoHS

Factory Tour Video: Watch Now

FAQ: Buy Niraparib Wholesale – Your Questions Answered

Real User Reviews: Niraparib from Global Technology

"Switched for buy niraparib wholesale—quality exceeded expectations, 25% cheaper!"

John D., Purchasing Manager, PharmaUS Inc. ★★★★★

"High-purity niraparib API, fast delivery. Highly recommend."

Lisa K., Technical Director, BioGen Labs ★★★★★

"GMP niraparib manufacturer China done right—zero issues in scale-up."

Tom S., Ops Manager, GlobalMed ★★★★★

"Niraparib supplier with OEM support—saved us months."

Anna M., Supply Chain Lead, HealthCorp ★★★★★

Secure Your Niraparib API Supply Now – Limited Q4 Stock!

10% off first order | Free samples (1-5g) | 100% money-back if not satisfied

Dr. Emily Chen, PhD

Senior Pharmaceutical Chemist & API Expert, Global Technology Co., Ltd. With 18 years in API production, including 10+ years leading niraparib synthesis scale-up. Published in J. Med. Chem., FDA audit veteran.