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Oncology · HPAPI · OEB4/5

Paclitaxel API Supplier

Name: Paclitaxel API
Brand: Generic Specialty Group
Availability: InStock

CAS 33069-62-4 · Oncology HPAPI · OEB4/5 · Taxane

GMP-certified Paclitaxel API — high potency oncology active (OEB4/5). USDMF on file. Full containment documentation, impurity profile, and GMP certificate included in every inquiry.

Request Complete Source Quote View Specifications

Purity≥99.5%HPLC

MOQ100 gHPAPI containment required

RegulatoryUSDMFOEB4/5 docs included

Response24 hrFull dossier

OriginMultiIndia / China

Technical Specifications

Paclitaxel API — Full Technical Profile

INN / Generic Name	Paclitaxel
CAS Number	33069-62-4
Molecular Formula	C₄₇H₅₁NO₁₄
Molecular Weight	853.9 g/mol
Mechanism / Class	Microtubule stabiliser — inhibits cell division (antimitotic)
Therapeutic Use	Breast, ovarian, lung, and other solid tumour cancers
Purity (HPLC)	≥99.5%
Appearance	White to off-white crystalline powder
Storage	Room temperature (15–30°C); protected from light
MOQ (commercial)	100 g
MOQ (R&D)	1 g – 10 g
Lead Time	4–8 weeks
Regulatory Filings	USDMF
Country of Origin	India / China

Regulatory Documentation

Complete Source Quote — What's Included

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

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Certificate of Analysis

Full CoA — assay ≥99.5%, related substances, residual solvents, loss on drying, heavy metals.

✓ Included

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USDMF on File

US Drug Master File active. Reference letter for FDA oncology ANDA/NDA submissions on request.

✓ On File

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OEB4/5 Containment Docs

Full occupational exposure band documentation, PPE requirements, handling protocols, and engineering controls.

✓ Included

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Impurity Profile

Full characterisation per ICH Q3A — baccatin III, 10-deacetyl paclitaxel, and all process-related impurities.

✓ Included

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Stability Data

ICH Q1A stability data — RT (15–30°C) long-term and accelerated conditions.

✓ Included

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GMP Certificate

USFDA-inspected and WHO-GMP certified manufacturing site. Audit reports available under NDA.

✓ Included

Market Context

Paclitaxel — Key Figures

$5B+

Global paclitaxel market

OEB 4/5

Containment class

≥99.5%

Purity specification

100 g

Minimum order

Complete Source Quote

Get Your Paclitaxel 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

Paclitaxel API Inquiry

Complete Source Quote · 24-hour response

Common Questions

Paclitaxel API — FAQ

What containment level is required for Paclitaxel?

Paclitaxel is classified as OEB4/5 (Occupational Exposure Band), requiring dedicated containment facilities during handling and manufacturing. Full containment documentation — OEB classification, PPE requirements, engineering control specifications — is included with every inquiry.

Is Paclitaxel available from semi-synthetic or natural sources?

We source pharmaceutical-grade Paclitaxel API primarily from semi-synthetic routes (from plant-derived precursors), ensuring consistent quality and sustainable supply. Source and synthetic route details are confirmed at quote stage.

What is the difference between Paclitaxel and Docetaxel?

Both are taxane-class oncology APIs. Paclitaxel (Taxol® reference) and Docetaxel (Taxotere® reference) differ in clinical indication profiles, formulation requirements, and toxicity profiles. Both are available through Generic Specialty with full HPAPI containment documentation.

Does Generic Specialty Group manufacture Paclitaxel?

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.

Paclitaxel API Supplier

Paclitaxel API — Full Technical Profile

Complete Source Quote — What's Included

Paclitaxel — Key Figures

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Paclitaxel API — FAQ

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