Fulvestrant 129453-61-8 — China API Manufacturer | EP USP R&D to Production

China Manufacturing Landscape for Fulvestrant

Fulvestrant (CAS 129453-61-8) is a selective estrogen receptor degrader (SERD) used as a critical treatment option for hormone receptor-positive metastatic breast cancer, particularly in patients who have progressed on prior endocrine therapy. As the only approved SERD and an increasingly important component of combination oncology regimens, global demand for Fulvestrant API continues to grow. China has developed specialized manufacturing capabilities for this complex steroidal compound, and our production facility serves as a reliable supply partner for generic pharmaceutical companies pursuing Fulvestrant formulation development and commercialization.

The synthesis of Fulvestrant requires sophisticated organic chemistry capabilities and stringent quality control due to its complex steroidal structure with multiple chiral centers. Our facility has invested in specialized synthesis infrastructure, advanced purification technology, and complete analytical capabilities to produce this high-value oncology API at commercial scale with consistent pharmacopeial compliance.

Manufacturing Process & Facility Overview

Fulvestrant production at our facility employs a multi-step chemical synthesis starting from estradiol, involving selective functionalization at the 7-alpha position to introduce the characteristic fluoroalkylsulfinyl side chain. The synthesis requires careful stereochemical control at each stage, achieved through optimized reaction conditions and chiral-selective transformations. Key process steps are conducted in jacketed glass-lined reactors with precise temperature control from -78°C to 150°C, enabling the cryogenic lithiation and subsequent coupling reactions central to the synthetic route.

The manufacturing suite features dedicated low-temperature reaction capabilities, inert atmosphere gloveboxes for moisture-sensitive chemistry, and advanced chromatographic purification systems including preparative HPLC with chiral stationary phase columns. The facility operates under controlled pharmaceutical conditions with segregated suites for intermediates and final API, validated cleaning protocols, and complete environmental monitoring. Annual production capacity is designed to meet growing global generic demand.

Quality Standards & Multi-Pharmacopeial Compliance

Our Fulvestrant API meets the quality specifications defined in European Pharmacopoeia (EP) and United States Pharmacopeia (USP) monographs. The extensive analytical testing program includes assay by validated HPLC method (purity ≥98.5%), chiral purity analysis confirming the correct stereochemical configuration, complete related substances profiling including known process-related and degradation impurities, identification by NMR, IR, and mass spectrometry, specific optical rotation measurement, residual solvent analysis, and heavy metals testing by ICP-MS.

Given the injectable route of administration for Fulvestrant formulations, our API production incorporates enhanced controls including low-endotoxin manufacturing processes, controlled bioburden throughout production, and thorough particulate matter assessment. The QC laboratory operates with state-of-the-art instrumentation including 400 MHz NMR, high-resolution mass spectrometry, and chiral HPLC platforms.

Regulatory Documentation & Export Support

We provide complete regulatory documentation to support customer ANDA and generic drug registration activities worldwide. Our documentation package includes Drug Master File (DMF) filed with the US FDA, detailed impurity profile with synthesis and characterization data for all specified impurities, ICH-compliant stability data (long-term, accelerated, and stressed conditions), complete process validation documentation, and analytical method validation reports per ICH Q2(R1). Standard shipment documents include batch-specific Certificates of Analysis, MSDS/SDS, and Certificates of Origin.

Our regulatory affairs team provides expert support for customer filing activities, including preparation of Quality Overall Summary (QOS) sections, responses to regulatory deficiency letters, and post-approval lifecycle management documentation.

Packaging & Global Logistics

Fulvestrant API is packaged in amber glass bottles with PTFE-lined closures, sealed under nitrogen atmosphere, and packed within secondary protective containers. Standard packaging units include 100 g, 500 g, 1 kg, and 5 kg configurations. All packaging operations are conducted under controlled environmental conditions with humidity and temperature monitoring to ensure product stability. Each package carries complete lot traceability and is labeled in compliance with GHS requirements.

International shipping utilizes temperature-controlled logistics (15-25°C) through qualified pharmaceutical freight providers. We offer FOB, CIF, and DDP Incoterms with primary routing through Shanghai for both air and ocean freight. Standard delivery times are 3-5 business days by air freight and 20-30 days by ocean freight to major global destinations.

Competitive Pricing & Supply Reliability

Our optimized synthetic route and efficient manufacturing processes enable competitive competitive pricing for Fulvestrant API. We offer structured pricing programs for both development-stage and commercial-stage customers, with scale-up pricing that becomes increasingly competitive as order volumes grow. Long-term supply agreements with price stability provisions are available for commercial customers committed to ongoing procurement.

Supply continuity is ensured through forward-planned production campaigns, strategic intermediate inventory, and qualified backup sourcing for critical raw materials. We maintain close communication with customers on production scheduling and provide advance notice of any factors that may affect delivery timelines. Our supply reliability record demonstrates consistent on-time performance exceeding 95% across all oncology API product lines.

Fulvestrant Technical Specifications