Atenolol CAS 29122-68-7 — China API Manufacturer | USP/EP/ChP R&D to Production

Product Overview & China Manufacturing Landscape

Atenolol is a selective beta-1 adrenergic receptor blocker prescribed globally for hypertension, angina pectoris, and cardiac arrhythmias. Identified by CAS number 29122-68-7 and molecular formula C₁₄H₂₂N₂O₃, atenolol remains one of the most widely consumed cardiovascular APIs worldwide, with inclusion on the WHO Essential Medicines List. China is the world’s largest producer of atenolol API, with over 20 NMPA-registered manufacturers and a combined annual production capacity exceeding 3,000 metric tons. This massive production scale has established China as the price-setting market for atenolol globally. Our facility in Shandong Province operates within one of China’s most established pharmaceutical manufacturing zones, benefiting from mature supply chains for key starting materials including 4-hydroxyphenylacetamide and epichlorohydrin.

Our Manufacturing Process & Facility Standards

Our atenolol manufacturing process follows a validated three-step synthesis: chloroacetylation of 4-hydroxyphenylacetamide, epoxide ring formation, and aminolysis with isopropylamine to yield the final API. Each step is optimized for high yield (overall process yield >75%) and minimal impurity generation. The synthesis is conducted in our 20,000 square meter quality-controlled production complex, which includes dedicated reactor halls with automated process control, and ISO 14644-1 Class 7 cleanroom suites for final crystallization, centrifugation, drying, and packaging operations. Quality is controlled through in-process checks at every stage: chiral purity verification by chiral HPLC (S-enantiomer ≤0.5%), intermediate purity gates by reverse-phase HPLC, and real-time reaction monitoring via inline FTIR probes. Our process capability index (Cpk) for assay exceeds 1.67, demonstrating that our manufacturing process consistently produces material well within specification limits. Batch size is typically 1,000-1,500 kg per campaign.

Quality Standards & Multi-Pharmacopeial Compliance

Our atenolol API is manufactured to meet all major pharmacopeial standards simultaneously: USP-NF, EP 11.0, ChP 2020, BP, and JP XVIII. Typical assay values are 99.5-100.5% on a dried basis. Rigorous quality control addresses all critical parameters: related substances (each individual impurity ≤0.10%, total ≤0.5%), optical purity (specific rotation within pharmacopeial range), residual solvents per ICH Q3C, heavy metals (≤10 ppm), sulfated ash (≤0.1%), and particle size distribution optimized for direct compression tablet manufacturing (D50: 15-30 μm). Every commercial batch undergoes full pharmacopeial testing plus extended characterization including DSC thermal analysis for polymorphic form confirmation, microbial limits testing, and bacterial endotoxin testing for injectable-grade requests. Complete COA documentation accompanies each shipment with all raw analytical data available upon request.

Regulatory Documentation & Registration Support

Our atenolol regulatory filing portfolio is extensive, reflecting years of international market supply. Current documentation includes: US FDA Type II DMF with unblemished annual update history, European CEP granted by EDQM, NMPA registration certificate, WHO prequalification status, active quality certificates from Chinese NMPA and multiple international audit bodies, and FDA facility registration. We have also filed DMFs in Canada, Brazil, Mexico, and South Korea. Our dedicated regulatory affairs department provides turnkey support for customer registration efforts, including CTD-formatted documentation packages, regulatory strategy consultation for market entry in new territories, coordination of on-site audits, and rapid response to technical questions from reviewing authorities. Our facility has been inspected 12 times by international regulatory bodies in the past decade with consistently favorable outcomes.

Packaging, Storage & Global Logistics

Atenolol API is packaged in pharmaceutical-grade double polyethylene bags placed inside fiber drums with secure closures. Standard packaging sizes are 5 kg, 10 kg, and 25 kg per drum, with bulk packaging of 50 kg drums available for large-volume customers. Storage conditions require controlled room temperature (below 30°C) in a dry environment, with a validated shelf life of 48 months. Our export logistics team coordinates shipments to over 40 countries, utilizing sea freight (typical transit 20-35 days depending on destination), China-Europe rail (16-18 days), and air freight (3-5 days). Given the high volume nature of atenolol orders, we frequently consolidate shipments in full container loads (FCL) for maximum freight economy. All export documentation including certificates of origin, free sale certificates, and phytosanitary documentation are prepared in-house.

Competitive Pricing & Supply Reliability

As one of the largest atenolol manufacturers in China, our production economics deliver industry-leading cost competitiveness. High-volume production runs, vertically integrated intermediate supply, and continuous process optimization result in pricing that represents exceptional value for pharmaceutical manufacturers worldwide. MOQ is 100 kg for new customers (sample quantities of 5-10 kg available for qualification), with standard commercial orders from 500 kg. We offer annual supply contracts with fixed quarterly pricing, volume rebate programs for purchases exceeding 5 metric tons per year, and consignment stock arrangements for strategic customers. Our production capacity of 50+ metric tons per month ensures zero allocation constraints even during demand surges. Raw material strategic reserves covering 6 months of production provide additional supply chain resilience against upstream disruptions.

Product Specifications