Bimatoprost CAS 155206-00-1 — China API Manufacturer | USP/EP R&D to Production

Product Overview & China Manufacturing Landscape

Bimatoprost is a synthetic prostamide analog used primarily in ophthalmic formulations for open-angle glaucoma and ocular hypertension, and increasingly in cosmetic applications for eyelash growth enhancement. With CAS number 155206-00-1 and molecular formula C₂₅H₃₇NO₄, bimatoprost is a high-value specialty API requiring advanced chiral synthesis capabilities. China’s bimatoprost manufacturing sector has matured significantly, with approximately 6 NMPA-registered producers and several additional facilities under construction or in registration phase. Annual Chinese production capacity is estimated at 5-8 metric tons, reflecting the relatively small dose requirements (0.3 mg/mL ophthalmic solutions) but high technical barriers to manufacture. Our facility specializes in prostaglandin and prostamide analog APIs, representing one of the most experienced Chinese manufacturers in this demanding chemical space.

Our Manufacturing Process & Facility Standards

Bimatoprost synthesis involves a complex multi-step stereoselective route requiring precise control of five chiral centers. Our process utilizes Corey lactone as a key chiral building block, proceeding through Wittig olefination, selective reduction, and amide coupling stages. The synthesis requires 12-15 individual reaction steps with an overall yield optimized to 8-12% from starting materials. Manufacturing is conducted in our dedicated prostaglandin production suite — a 3,000 square meter facility with ISO 14644-1 Class 6 (Class 1,000) cleanroom environments for final purification and processing stages. All reaction vessels and transfer lines are constructed from pharmaceutical-grade borosilicate glass or PTFE-lined stainless steel to prevent trace metal contamination. In-process controls are extensive: chiral HPLC at four critical stages to confirm diastereomeric and enantiomeric purity (≥99.0% de and ee), column chromatography intermediate purification with fraction analysis, and real-time reaction monitoring via inline UV spectroscopy. Typical batch size is 2-5 kg of finished API per campaign.

Quality Standards & Multi-Pharmacopeial Compliance

Our bimatoprost API meets USP-NF and European Pharmacopoeia standards, with testing protocols also aligned to ICH Q6A for full characterization. Typical assay values reach 99.0-100.5% on an anhydrous basis. Given the ophthalmic application of bimatoprost, quality control is particularly stringent: stereopurity is verified by chiral HPLC (each diastereomer ≤0.5%), related substances are controlled by gradient HPLC (total impurities ≤1.0%), residual solvents are tested against ICH Q3C Class 1 and 2 limits with expanded panel, heavy metals screening by ICP-MS (individual elements per ICH Q3D), bacterial endotoxins (≤5 EU/mg for ophthalmic-grade material), and particulate matter analysis. Each batch is characterized by DSC, TGA, and FTIR for identity and polymorphic form. Complete COA documentation accompanies every shipment, with analytical method transfer packages and reference standard samples available for customer QC laboratories.

Regulatory Documentation & Registration Support

Our regulatory documentation for bimatoprost includes: NMPA drug registration certificate, Chinese DMF, US FDA Type II DMF filed and referenced by multiple ANDA applicants, and European ASMF available for customer CEP/MAA referencing. Current quality certificates from provincial drug administration and third-party audit reports (SGS, Intertek) are maintained. Our facility is registered with the US FDA. Given the complexity of prostaglandin API registration, our regulatory team provides extensive technical support including: complete CTD 3.2.S documentation with full impurity characterization and structural elucidation of all specified impurities, genotoxic impurity risk assessment per ICH M7, elemental impurity assessment per ICH Q3D, and detailed starting material justification documentation. We support customer interactions with regulatory authorities and have facilitated successful registrations in the US, EU, India, and South Korea for bimatoprost products.

Packaging, Storage & Global Logistics

Bimatoprost API is packaged under nitrogen atmosphere in amber glass bottles sealed with PTFE-lined caps, then placed into aluminum cans with desiccant. Standard packaging sizes are 100 g, 500 g, 1 kg, and 5 kg units, reflecting the high potency and value of this API. Storage requires -20°C in an inert atmosphere protected from light, with a validated shelf life of 24 months under recommended conditions. Given the cold storage requirements, all international shipments utilize validated cold chain logistics with dry ice or gel pack temperature maintenance. We partner with specialized pharmaceutical cold chain carriers for door-to-door delivery. Air freight is the standard shipping mode with typical delivery times of 3-7 days to major global destinations. Every shipment includes calibrated temperature data loggers with downloadable records for the customer’s incoming inspection. Complete shipping documentation is prepared by our export team.

Competitive Pricing & Supply Reliability

Bimatoprost represents a premium specialty API, and our pricing reflects the significant technical investment in stereoselective synthesis while maintaining strong competitiveness versus European and Japanese sources. Competitive pricing provides savings of 40-55% compared to Western manufacturers of equivalent quality. MOQ is 500 g for initial qualification, with commercial orders typically from 1 kg upward. Given the high value per kilogram, we provide flexible lot sizing to match customer demand cycles. Pricing is quoted per gram or per kilogram depending on order volume, with significant tiering for annual commitments above 10 kg. Our production planning allocates capacity 3-6 months in advance; we recommend customers place forecasts quarterly to ensure allocation. Raw material (Corey lactone) inventory is maintained for 6+ months of production to buffer against upstream supply fluctuations.

Product Specifications