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Oncology · HPAPI

Docetaxel API Supplier

CAS 114977-28-5  ·  Oncology HPAPI · Taxane · Semi-synthetic

GMP-certified Docetaxel API — a leading HPAPI oncology active used in breast, prostate, gastric, and NSCLC treatment. USDMF on file. Full containment documentation with every inquiry.

Request Complete Source Quote View Specifications
Purity≥99.0%HPLC
MOQ200 gHPAPI handling required
RegulatoryUSDMFOn file
Response24 hrFull dossier
OriginMultiIndia / China
Technical Specifications

Docetaxel API — Full Technical Profile

INN / Generic NameDocetaxel
CAS Number114977-28-5
Molecular FormulaC₄₃H₅₃NO₁₄
Molecular Weight807.9 g/mol
Mechanism / ClassMicrotubule stabiliser — promotes tubulin polymerisation
Therapeutic UseBreast cancer, NSCLC, prostate, gastric, and head/neck cancers
Purity (HPLC)≥99.0%
AppearanceWhite to almost white powder or clumps
StorageStore below 25°C; protect from light and moisture
MOQ (commercial)200 g
MOQ (R&D)5 g – 25 g
Lead Time4–8 weeks
Regulatory FilingsUSDMF
Country of OriginIndia / China
Regulatory Documentation

Complete Source Quote — What's Included

Every Docetaxel API inquiry returns a complete regulatory package in 24 hours.

📋
Certificate of Analysis
Full CoA — assay ≥99.0%, related substances (10-deacetyl-docetaxel, related impurities), residual solvents, water content.
✓ Included
🇺🇸
USDMF on File
US Drug Master File active. Reference letter provided for FDA oncology drug applications.
✓ On File
⚗️
HPAPI Containment Docs
OEB classification, PPE specifications, handling SOPs, and engineering controls for safe processing.
✓ Included
🧪
Impurity Profile
Full ICH Q3A impurity characterisation — all taxane-related and process impurities profiled.
✓ Included
📊
Stability Data
ICH Q1A long-term (25°C/60% RH) and accelerated stability data.
✓ Included
🏭
GMP Certificate
Current GMP certificate from FDA-inspected manufacturing site.
✓ Included
Market Context

Docetaxel — Key Figures

$2.5B+
Global docetaxel market
5+
Major oncology indications
≥99.0%
Purity specification
200 g
Commercial MOQ
Complete Source Quote

Get Your Docetaxel API Quote

Submit your requirements. We'll respond with a complete package within 24 business hours.

  • Certificate of Analysis (CoA)
  • USDMF — reference letter / status
  • Full impurity profile per ICH Q3A
  • Stability data summary
  • GMP certificate + site details
  • Pricing, MOQ, and lead time
  • Country of origin confirmation
Docetaxel API Inquiry
Complete Source Quote · 24-hour response
PDF · DOC · XLS · Max 10 MB

✓ 24-hour response  ·  [email protected]

Common Questions

Docetaxel API — FAQ

Is Docetaxel available as a semisynthetic API?
Yes — we source pharmaceutical-grade Docetaxel API produced via semi-synthetic processes from 10-deacetylbaccatin III precursors. This ensures quality consistency and regulatory compliance. Full synthesis route documentation is available under NDA.
What HPAPI containment documentation is provided?
Every Docetaxel inquiry includes full HPAPI documentation: OEB band classification, recommended PPE, engineering controls (isolator/RABS specifications), handling SOPs, and emergency response procedures.
What regulatory markets is Docetaxel supplied for?
Our Docetaxel API is suitable for FDA (USA), EMA (EU), Health Canada, TGA (Australia), and other regulated markets. USDMF is on file. We confirm applicable filings at the quote stage.
Does Generic Specialty Group manufacture Docetaxel?
No — Generic Specialty Group is an independent API sourcing partner, not a manufacturer. We source from a curated network of GMP-audited manufacturers globally, giving you access to multiple qualified sources and competitive pricing without being tied to a single facility.
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