Vincristine Sulfate 2068-78-2 — China API Manufacturer | USP/EP/BP R&D to Production

China Manufacturing Landscape for Vincristine Sulfate

Vincristine Sulfate (CAS 2068-78-2) is a vinca alkaloid antineoplastic agent derived from the periwinkle plant (Catharanthus roseus), used as a critical component of combination chemotherapy regimens for acute lymphoblastic leukemia (ALL), Hodgkin’s and non-Hodgkin’s lymphomas, neuroblastoma, Wilms’ tumor, and various other malignancies. Listed on the WHO Model List of Essential Medicines, Vincristine is an indispensable oncology API whose uninterrupted supply is a matter of global public health significance. Chinese manufacturers have developed sophisticated plant extraction and semi-synthetic production capabilities that position China as a key global source for Vincristine Sulfate API.

Our production facility specializes in vinca alkaloid production, with vertically integrated operations spanning agricultural cultivation of Catharanthus roseus, plant material processing and extraction, alkaloid isolation and purification, and pharmaceutical-grade salt formation. This end-to-end capability, combined with China’s favorable climate for periwinkle cultivation in southern provinces, provides a reliable and cost-effective supply base for this essential anticancer API.

Manufacturing Process & Facility

Vincristine Sulfate production begins with harvesting of dried Catharanthus roseus aerial parts from managed agricultural plots in Yunnan, Guangxi, and Hainan provinces, where tropical and subtropical climates favor optimal alkaloid accumulation. The plant material undergoes acid-base extraction to obtain a crude alkaloid fraction, followed by solvent partitioning and multi-step chromatographic separation to isolate Vincristine from the complex mixture of structurally related indole alkaloids including vinblastine, catharanthine, and vindoline.

An alternative semi-synthetic route couples catharanthine and vindoline precursors through biomimetic oxidative coupling to form the anhydrovinblastine intermediate, which is then selectively oxidized to yield Vincristine. Both extraction and semi-synthetic routes are employed at our facility to ensure supply flexibility. Final purification by preparative HPLC, followed by sulfate salt formation and lyophilization, yields pharmaceutical-grade Vincristine Sulfate. The facility maintains ISO Class 5 cleanroom suites for sterile-grade processing, with complete containment infrastructure for handling this potent cytotoxic API. Annual production capacity is 50 kg of Vincristine Sulfate.

Quality Standards & Multi-Pharmacopeial Compliance

Vincristine Sulfate API from our facility meets USP, EP, and BP pharmacopeial monograph specifications. HPLC purity exceeds 98.0%, with the critical vinblastine impurity controlled below 0.5% and total related alkaloid impurities within specified limits. Potency by UV spectrophotometric assay or HPLC is consistently within 95.0-105.0% of label claim. Identity is confirmed by IR spectroscopy, UV-Vis absorption, specific optical rotation, and HPLC retention time comparison.

Analytical testing encompasses HPLC assay and related substances, specific optical rotation, water content by Karl Fischer, pH measurement, sulfate content, residual solvents by headspace GC, elemental impurities by ICP-MS, bacterial endotoxin testing by LAL method, and sterility testing for sterile-grade product. Occupational exposure limit monitoring and surface contamination testing are performed throughout manufacturing to verify containment effectiveness. ICH Q1A stability studies support a 24-month shelf life under cold storage conditions.

Regulatory Documentation

We maintain complete regulatory documentation for Vincristine Sulfate, including US FDA Type II Drug Master File, EU ASMF, and WHO Prequalification-compatible packages. Full CTD Module 3.2.S documentation covers detailed manufacturing process descriptions for both extraction and semi-synthetic routes, starting material specification and control (including botanical identity and geographical origin documentation for plant material), control strategy for vinca alkaloid impurities, and validated analytical methods. For sterile-grade product, aseptic process validation, lyophilization cycle validation, and container-closure integrity data are provided. Occupational health and safety documentation, including OEL determination reports and containment validation data, is available upon request.

Packaging & Logistics

Vincristine Sulfate API is packaged in amber glass vials or bottles with validated closure systems, in quantities of 1 g, 5 g, 10 g, and 50 g per unit. All packaging is designed for potent compound containment with tamper-evident seals and secondary containment overwrap. Sterile-grade product is additionally packaged under aseptic conditions with validated sterile closure systems. All shipments require cold chain management (2-8°C) via validated temperature-controlled packaging with continuous monitoring data loggers. International cold chain air freight from Shanghai reaches major destinations within 5-8 business days. Hazardous materials shipping documentation per IATA regulations is provided for all Vincristine Sulfate shipments.

Competitive Pricing & Supply Reliability

Vincristine Sulfate pricing reflects the inherent complexity and cost intensity of vinca alkaloid production from plant material, while our vertically integrated operations ensure competitiveness against alternative global sources. We offer development-stage pricing for initial evaluation and bioequivalence study supply, transitioning to commercial contract pricing for ongoing procurement. Lead times are typically 8-12 weeks for new orders, reflecting the agricultural and multi-step processing nature of production. Strategic supply agreements with dedicated production allocation ensure uninterrupted availability for customers with critical oncology pipeline requirements. Our commitment to essential medicine supply is demonstrated by participation in WHO and international procurement programs for affordable cancer treatment access.

Vincristine Sulfate Specifications