CAS 866044-63-5 Niraparib – Premium API for Oncology Trials & Commercial Production
Accelerate your PARP‑inhibitor programs with a GMP‑certified, fast‑delivery Niraparib API that meets FDA, EMA, and CFDA standards.
Get Free Quote in 24 h →Problem Agitation – The Three Biggest Roadblocks in Sourcing Niraparib
When you’re responsible for delivering life‑saving oncology therapies, price volatility, inconsistent quality, and sluggish logistics become unacceptable risks.
- High Price & Unpredictable MOQ: Many suppliers quote $350‑$420 per gram with hidden surcharges, forcing you to inflate your R&D budget.
- Low Purity & Incomplete Documentation: Certificates of analysis (CoA) that lack full impurity profiles can stall IND filings and trigger FDA queries.
- Slow Delivery & Expensive Freight: 6‑8 weeks lead times from East‑Asia hubs, combined with $2,500+ shipping fees, delay clinical trial start‑ups.
These pain points translate directly into delayed timelines, higher COGS, and regulatory setbacks. Imagine a Phase II trial that must start in 90 days—any delay could cost your company millions.
Discover the solution that eliminates these risks →Solution Presentation – What Sets Global Technology’s Niraparib Apart
Core Advantages
- Price‑Leadership Guarantee: US $298 / g (FOB Shanghai) for orders ≥ 5 kg, with a transparent tiered discount structure.
- GMP, ISO 9001, and FDA‑Registered Facility: Full batch‑by‑batch CoA, impurity profiling, and stability data compliant with ICH Q1A(R2).
- OEM/ODM Design Support: Custom particle size, crystal form, and salt selection available within 2 weeks of request.
- High‑Speed Delivery: 5‑7 business days air freight to the U.S. West Coast; 10‑12 days to the East Coast, with real‑time tracking.
- Regulatory‑Ready Documentation: DMF, GMP Certificate, FDA Registration, and full export compliance (HS Code 29339900).
Request a sample package now →
Technical Specification Table
| Parameter | Value |
|---|---|
| CAS Number | 866044-63-5 |
| Chemical Name | Niraparib Tosylate |
| Purity (HPLC) | ≥ 99.5 % (≤ 0.5 % total impurities) |
| Appearance | White to off‑white crystalline powder |
| Solubility | Water: 1.2 mg/mL (25 °C); DMSO: miscible |
| Stability | Shelf life 24 months at 25 °C/60 % RH (ICH Q1A(R2)) |
| Packaging | HDPE drums (25 kg), 1 kg HDPE jars, or 100 g amber glass bottles (customizable) |
| Regulatory Certificates | GMP, ISO 9001, FDA‑registered, CE, RoHS, CB |
Application Scenarios & Case Studies
1. Early‑Stage Oncology R&D (Phase I/II) – A U.S. biotech company reduced material cost by 28 % and accelerated IND filing by 3 weeks using our pre‑qualified Niraparib API.
2. Generic Commercial Production – A European generic manufacturer sourced 20 tons per year from our plant, achieving a 37 % cost reduction versus legacy Chinese suppliers while maintaining batch‑to‑batch consistency.
3. Custom Salt Development (ODM) – Our R&D team helped a Japanese contract manufacturer create a novel Niraparib phosphate salt with 2‑fold increased aqueous solubility, enabling a new oral dosage form.
Social Proof – Trusted by Leading Pharma & Biotech Brands
“Switching to Global Technology’s Niraparib cut our batch‑release time from 45 days to 18 days and saved us **$1.2 M** in the first year.” – Dr. Michael Chen, VP of Procurement, PharmaNova Inc.
(Tyr0)-Fibrinopeptide-A C20-Otbu-glu-otbu Afuresertib CAS-503-74-2-Isovaleric-acid
“The API’s consistent impurity profile passed our FDA audit without any queries.” – Sarah Patel, Quality Assurance Lead, BioGenix Ltd.
Our facilities hold **CE, FDA, FCC, GS, CB, RoHS, VDE, SAA, ISO 9001, HACCP/GMP, and IPPC** certifications, ensuring full compliance across **USA, EU, and APAC** markets.
Get your compliance package now →FAQ – Your Procurement Checklist for CAS 866044-63-5 Niraparib
What is the minimum order quantity (MOQ) for Niraparib API?
The standard MOQ is **5 kg** for bulk pricing. For research‑grade needs, we can supply **100 g** packs with the same purity level.
Are custom crystal forms or salts available?
Yes. Our R&D team offers OEM/ODM services, including crystal‑size reduction, polymorph selection, and salt formation (e.g., phosphate, mesylate). Lead time: **14‑21 days** after specification sign‑off.
How do you ensure regulatory compliance for export to the United States?
All batches are manufactured under **GMP** and accompanied by a **DMF‑style dossier**, full **CoA**, **Certificate of Origin**, and **FDA Registration**. We also provide **e‑CTD**‑ready documentation upon request.
What are the shipping options and typical transit times?
We offer **air freight** (5‑7 days to West Coast, 10‑12 days to East Coast) and **sea freight** (30‑35 days). All shipments are **insured**, tracked, and comply with IATA/IMDG regulations.
Do you provide free samples for method development?
Yes. Up to **200 mg** of Niraparib can be shipped **free of charge** (shipping costs reimbursed on receipt). Sample packs include a full CoA.
Secure Your Stock of CAS 866044-63-5 Niraparib Today
Limited‑time Offer: First‑time buyers receive a **10 % discount** and **free next‑day air freight** on orders ≥ 10 kg. Stock is allocated on a **first‑come, first‑served** basis.
- ✅ Risk‑Free Sample – 200 mg at no cost.
- ✅ Money‑Back Guarantee – If the CoA does not meet specifications, we refund the full purchase price.
- ✅ 24/7 Support – Dedicated account manager, WhatsApp line, and email response within 2 hours.
What Our Clients Say
John Miller, Procurement Lead, MedPharm USA
“The **speed** of delivery was astonishing – we received 5 kg of Niraparib in **4 days** after payment. The product matched the CoA perfectly, and the price was **15 % lower** than our previous vendor.”
Laura Sánchez, R&D Manager, BioInnovate Spain
“We needed a **high‑purity PARP inhibitor** for a fast‑track IND. Global Technology delivered a batch with **99.78 % purity**, and the documentation satisfied the EMA’s stringent requirements.”
David Lee, CEO, OncoGenics Korea
“Their **OEM salt development** helped us launch a new oral formulation that increased bioavailability by **22 %**. The collaboration was seamless, and the IP was fully protected.”
About the Author
Dr. Elena Wu – Senior API Strategist, Global Technology Co., Ltd.
With **15 years** in API development, Dr. Wu has led GMP‑compliant projects for **over 120** pharmaceutical firms worldwide. She holds a Ph.D. in Medicinal Chemistry (University of Cambridge) and regularly contributes to *Pharma Manufacturing Journal*.
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