China Manufacturing Landscape for Paclitaxel (CAS 33069-62-4)
Paclitaxel, the landmark taxane chemotherapy agent used across multiple solid tumor indications, is one of China’s most strategically important oncology API exports. Our production facility in Yunnan Province operates adjacent to sustainable Taxus (yew tree) plantations, providing unique access to the plant-derived starting material that underpins our semi-synthetic production process. As a vertically integrated manufacturer from biomass sourcing through final API, we offer pharmaceutical companies unmatched supply security and competitive pricing for this essential oncology compound.
China is the world’s largest producer of Paclitaxel API, leveraging both abundant Taxus biomass resources and advanced semi-synthetic and cell culture technologies. Our facility combines sustainable botanical sourcing with state-of-the-art purification technology to deliver injectable-grade Paclitaxel that meets the most stringent international quality standards.
Manufacturing Process & Facility
Our Paclitaxel production utilizes a semi-synthetic approach starting from 10-deacetylbaccatin III (10-DAB III) extracted from renewable Taxus needle biomass. The semi-synthetic conversion involves side-chain attachment through a well-characterized multi-step chemical process, followed by extensive chromatographic purification and controlled crystallization. This approach is both commercially viable and environmentally sustainable, avoiding destructive harvesting of Taxus bark.
Facility features:
- On-site extraction facility processing 500+ metric tons of Taxus biomass annually
- Dedicated semi-synthesis suites with cytotoxic compound containment (OEL <1 μg/m³)
- Multi-column preparative HPLC systems for high-resolution purification
- ISO Class 7 cleanroom with isolator technology for final processing
- Annual production capacity: 1.5 metric tons of pharmaceutical-grade Paclitaxel
- Sustainable Taxus plantation partnerships ensuring long-term biomass supply
Our high-containment infrastructure includes negative-pressure suites, closed-system material transfer, and validated decontamination procedures, meeting all requirements for cytotoxic API manufacturing.
Quality Standards & Multi-Pharmacopeial Compliance
Our Paclitaxel API is produced to injectable-grade quality, meeting USP, EP, and JP specifications:
| Parameter | Specification | Test Method |
|---|---|---|
| Appearance | White to off-white powder | Visual |
| Identification | Positive by IR, HPLC, specific rotation | IR/HPLC/Polarimetry |
| Assay (anhydrous basis) | 97.0–102.0% | HPLC |
| Related Substances (total) | ≤2.0% | HPLC |
| Any Single Impurity | ≤0.5% | HPLC |
| 7-Epi-Paclitaxel | ≤0.5% | HPLC |
| 10-DAB III (starting material) | ≤0.1% | HPLC |
| Bacterial Endotoxins | ≤0.5 EU/mg | LAL |
| Residual Solvents | Meets ICH Q3C | GC-HS |
| Elemental Impurities | Meets ICH Q3D (parenteral) | ICP-MS |
Regulatory Documentation
Our Paclitaxel regulatory dossier supports customer injectable drug product registrations globally:
- US FDA Drug Master File (Type II) — active, with successful FDA pre-approval inspection
- EU CEP (Certificate of Suitability) — granted
- Japan PMDA DMF — filed and active
- WHO Prequalification Programme supporting documentation
- China NMPA registration for cytotoxic API manufacturing
- Complete process validation and cleaning validation packages
- ICH Q1A stability data with 36-month long-term and photostability results
- Elemental impurity risk assessment per ICH Q3D for parenteral administration
- Containment and occupational safety validation reports
Letters of Authorization for DMF cross-reference are issued within 48 hours. Our regulatory team provides active support throughout the customer’s filing and inspection process.
Packaging & Logistics
Paclitaxel packaging reflects injectable-grade and cytotoxic compound requirements:
- Primary: Amber glass bottles, nitrogen-flushed, with PTFE-lined caps
- Secondary: Cytotoxic-labeled, tamper-evident outer containers (5g, 10g, 50g, 100g, 500g, 1 kg)
- Tertiary: UN-certified dangerous goods packaging per applicable regulations
- Storage: 2-8°C, protected from light; cold-chain shipping mandatory
- Shelf life: 36 months under recommended storage conditions
Shipments are handled by specialized cytotoxic/cold-chain pharmaceutical logistics providers. Full dangerous goods documentation, export permits, and customs clearance support are provided.
Competitive Pricing & Supply Reliability
Our vertical integration from Taxus biomass sourcing through final API provides fundamental cost advantages:
- Direct access to Taxus needle biomass from managed plantations
- In-house 10-DAB III extraction eliminating intermediate procurement costs
- Optimized semi-synthetic process with high conversion yield
- Dedicated cytotoxic facility with no campaign changeover overhead
We supply quantities from 1g analytical reference standard to multi-hundred kilogram commercial orders. Priority supply agreements are available for essential oncology medicine programs. Contact our oncology API division for current pricing, sample availability, and technical documentation packages.