Latanoprost 130209-82-4 — China API Manufacturer | EP USP R&D to Production

China Manufacturing Landscape for Latanoprost

Latanoprost (CAS 130209-82-4) is a prostaglandin F2α analogue and the most widely prescribed topical medication for the reduction of elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension. As a first-line glaucoma treatment with extensive global usage, reliable supply of high-purity Latanoprost API is essential for ophthalmic pharmaceutical manufacturers. Our production facility in China has developed specialized prostaglandin synthesis capabilities, providing pharmaceutical companies with a dependable and cost-effective source of Latanoprost API.

The synthesis of Latanoprost requires advanced organic chemistry expertise, particularly in prostaglandin chemistry involving multiple stereocenters and sensitive functional groups. Our facility has invested significantly in the specialized equipment, skilled personnel, and analytical infrastructure necessary for consistent production of this complex molecule at commercial scale, positioning us as a trusted supplier for the global generic ophthalmic market.

Manufacturing Process & Facility Overview

Latanoprost production at our facility follows a convergent multi-step synthesis beginning with the Corey lactone aldehyde as a key starting material. The synthesis involves Wittig-type olefination, stereoselective reduction, protective group manipulation, and final esterification to yield the isopropyl ester prodrug form. Each step requires careful control of stereochemistry, and our process incorporates chiral chromatographic resolution and asymmetric synthesis techniques to ensure the correct stereoconfiguration.

The manufacturing suite is equipped with cryogenic reactors capable of maintaining temperatures to -100°C for critical low-temperature transformations, high-vacuum distillation systems, preparative HPLC with chiral stationary phases for stereoisomer separation, and controlled crystallization equipment. All production occurs under controlled pharmaceutical conditions in dedicated suites with inert atmosphere capabilities, temperature and humidity control, and complete environmental monitoring. The facility utilizes validated cleaning protocols between product campaigns.

Quality Standards & Multi-Pharmacopeial Compliance

Our Latanoprost API meets the quality specifications defined in European Pharmacopoeia (EP) and United States Pharmacopeia (USP) monographs. The complete analytical program includes assay by validated HPLC method (purity ≥98.0%), stereochemical purity assessment confirming correct configuration at all chiral centers, related substances profiling including 15-epi-Latanoprost and other known impurities, identification by NMR and IR spectroscopy, specific optical rotation measurement, residual solvent analysis, and heavy metals testing by ICP-MS.

Given the ophthalmic application and the exacting quality requirements of eye drop formulations, our production and testing incorporate additional controls including low bioburden manufacturing, particulate matter assessment, and complete stability evaluation under both standard and in-use conditions. The QC laboratory operates with high-field NMR, high-resolution mass spectrometry, and validated chiral HPLC methods for complete stereochemical characterization.

Regulatory Documentation & Export Support

We maintain complete regulatory documentation to support customer ANDA filings and generic drug registrations. Available documentation includes US FDA Drug Master File (DMF), detailed impurity profile with synthesis and characterization data for all specified impurities, ICH-compliant stability data packages, process validation documentation, analytical method validation reports, and complete starting material and intermediate specifications. Batch-specific Certificates of Analysis, MSDS/SDS, and Certificates of Origin accompany every shipment.

Our regulatory affairs team provides expert support for customer ophthalmic drug filing activities, including review of quality sections, responses to regulatory agency questions, and preparation of post-approval variation documentation.

Packaging & Global Logistics

Latanoprost API is an oily liquid at room temperature and is packaged in amber glass bottles with PTFE-lined closures, sealed under nitrogen atmosphere. Standard packaging units include 10 g, 50 g, 100 g, and 500 g configurations. All packaging operations are conducted under controlled temperature conditions with strict light protection and inert atmosphere to prevent oxidative degradation. Each container carries complete lot traceability information.

International shipments are arranged through pharmaceutical cold chain logistics providers, with temperature-controlled shipping (2-8°C) as standard to maintain product stability. We offer FOB, CIF, and DDP Incoterms with primary routing through Shanghai. Air freight is the standard shipping mode for Latanoprost due to the temperature sensitivity, with delivery within 3-5 business days to most global destinations. Ocean freight with reefer containers is available for larger shipments.

Competitive Pricing & Supply Reliability

Our optimized synthetic route and efficient manufacturing processes enable competitive competitive pricing for Latanoprost API. We provide structured pricing programs for development-stage customers requiring smaller quantities and commercial-scale customers with ongoing demand, with volume-based discounts and annual supply agreement options. Our pricing reflects the direct manufacturer advantage without intermediary cost additions.

Supply continuity is maintained through planned production campaigns, strategic intermediate stockpiling, and qualified backup sourcing for critical starting materials. Our Latanoprost supply record demonstrates consistent on-time delivery performance exceeding 95%, supported by dedicated account management and proactive customer communication on production scheduling and delivery timelines.

Latanoprost Technical Specifications