Chloramphenicol CAS 56-75-7 — China API Manufacturer | ChP/USP/EP/BP R&D to Production

Product Overview & China Manufacturing Landscape

Chloramphenicol is a broad-spectrum bacteriostatic antibiotic effective against a wide range of gram-positive and gram-negative organisms, with particular importance in treating bacterial meningitis, typhoid fever, and serious ophthalmic infections. Identified by CAS number 56-75-7 and molecular formula C₁₁H₁₂Cl₂N₂O₅, chloramphenicol remains on the WHO Essential Medicines List and is widely manufactured for both human and veterinary pharmaceutical applications. China is the world’s largest chloramphenicol producer by a significant margin, with over 25 NMPA-registered manufacturers and combined annual production capacity exceeding 5,000 metric tons. This dominant position reflects decades of accumulated manufacturing expertise and competitive raw material supply chains concentrated in Hebei, Shandong, and Zhejiang provinces. Our facility is among the top five Chinese producers by volume, with dedicated chloramphenicol production lines operating continuously since 2005.

Our Manufacturing Process & Facility Standards

Our chloramphenicol production employs a synthetic route from p-nitroacetophenone, proceeding through bromination, amino alcohol formation via stereoselective reduction, dichloroacetylation, and final crystallization to yield the threo-isomer with high diastereomeric purity. The entire synthesis is optimized for atom economy and minimal waste generation, with solvent recovery rates exceeding 90%. Production takes place in our 25,000 square meter production facility featuring stainless steel reactor systems ranging from 3,000 to 10,000 liter capacity, and ISO 14644-1 Class 7 cleanroom environments for final crystallization, drying, milling, and packaging. In-process quality controls include stereochemical purity monitoring by chiral HPLC (threo:erythro ratio ≥99:1), intermediate assay verification, solvent residue checks at each isolation stage, and real-time particle size monitoring during the milling operation. Our process capability delivers outstanding batch consistency with assay RSD below 0.6% across hundreds of production batches annually.

Quality Standards & Multi-Pharmacopeial Compliance

Our chloramphenicol API meets all major international pharmacopeial standards: ChP 2020, USP-NF, EP 11.0, BP, and JP XVIII. Typical assay values are 99.0-100.5% on a dried basis. Key quality parameters include: specific optical rotation (within narrow pharmacopeial range confirming correct stereochemistry), related substances by HPLC (total impurities ≤0.5%), residual solvents per ICH Q3C, loss on drying (≤0.5%), sulfated ash (≤0.1%), heavy metals (≤10 ppm), and clarity/color of solution. For ophthalmic-grade chloramphenicol, additional testing includes bacterial endotoxin (≤0.5 EU/mg), particulate matter, and enhanced microbial limits. We maintain separate production campaigns for pharmaceutical human-grade and veterinary-grade material with full batch segregation. Each shipment includes complete COA documentation specifying which pharmacopeial standard was applied, with raw chromatographic data available electronically upon request.

Regulatory Documentation & Registration Support

Our chloramphenicol regulatory portfolio reflects our extensive global supply history. Available documentation includes: NMPA drug registration certificate, US FDA Type II DMF, European CEP granted by EDQM, WHO prequalification, quality certificates from Chinese provincial authority, and FDA establishment registration. We have additionally filed DMFs in Canada, Brazil, South Korea, and multiple ASEAN and African regulatory authorities. Our facility has been successfully inspected by the US FDA, EU member state inspectorates, WHO prequalification team, and ANVISA, with no critical findings in the past decade. Regulatory support services encompass complete CTD Module 3.2.S documentation, variation filing support when process changes occur, and coordination of customer-sponsored quality audits. For WHO Essential Medicine programs and donor-funded procurement, we provide specially formatted dossiers meeting WHO prequalification technical requirements.

Packaging, Storage & Global Logistics

Chloramphenicol API is packaged in pharmaceutical-grade double polyethylene bags within fiber drums or aluminum drums. Standard packaging sizes include 5 kg, 10 kg, 25 kg, and 50 kg per drum, with jumbo packaging of 100 kg drums available for high-volume customers. Storage conditions require room temperature (below 25°C) in a dry, light-protected environment, with validated shelf life of 48 months. Our export logistics operation is highly experienced with chloramphenicol shipments, handling over 200 international shipments annually to 50+ countries. Standard transit options include sea freight (20-35 days depending on destination), China-Europe rail (14-18 days), and air freight (3-7 days). We routinely handle full container load (FCL) and less-than-container-load (LCL) shipments. Complete export documentation including commercial invoices, certificates of origin, free sale certificates, WHO CPP certificates, and phytosanitary documentation are prepared by our logistics team.

Competitive Pricing & Supply Reliability

As one of the largest chloramphenicol manufacturers in China, we benefit from exceptional production economies of scale. Our fully integrated manufacturing — from starting material synthesis through finished API — combined with high-volume continuous production delivers the most competitive pricing available in the global market. MOQ is 100 kg for new customers, with standard commercial orders from 500 kg. For institutional procurement (WHO, UNICEF, donor-funded programs), we offer special pricing structures and pre-positioned inventory arrangements. Volume-based pricing tiers apply for annual purchases above 5 metric tons, with additional discounts for purchases exceeding 20 metric tons. Long-term supply agreements of 12-36 months with fixed or indexed pricing are standard for our key accounts. Our production capacity of 80+ metric tons per month ensures no allocation constraints, and raw material reserves cover 6 months of full production.

Product Specifications