Anticholinergic and emergency treatment APIs have passed multiple international quality validations.

Henan Purui Pharmaceutical Co., Ltd., a company with nearly two decades of experience in the field of specialty active pharmaceutical ingredients (APIs), recently announced that its anticholinergic and emergency API series products have completed a new round of process optimization and quality system upgrades. Many products have successfully passed rigorous quality audits by domestic and international clients, further solidifying its industry position as a core API manufacturer and important export base in China.

Purui Pharmaceutical currently possesses an independent API R&D center and pilot-scale amplification platform, enabling it to provide full-chain API services from laboratory route development and impurity profile research to commercial production. Its core products cover anticholinergic APIs (such as those used in the treatment of chronic respiratory diseases and digestive system spasms) and emergency APIs (used in intensive care, poisoning rescue, and preoperative medication). The purity, stability, and batch-to-batch consistency of its products have reached internationally advanced levels.

The company strictly adheres to national GMP standards in its production. Its API production workshop is equipped with advanced synthesis reactors, efficient separation and purification systems, and closed-loop drying equipment. Key process parameters are automatically monitored and recorded through a DCS (Distributed Control System). In terms of quality control, PURE Pharmaceutical's Quality Inspection Center possesses dozens of high-precision analytical instruments (including high-performance liquid chromatographs, gas chromatographs, and UV-Vis spectrophotometers), implementing full lifecycle management of APIs from starting materials and intermediates to finished products to ensure that every batch of products meets domestic and international pharmacopoeia standards.

Notably, leveraging its technological accumulation in the field of anticholinergic APIs, PURE Pharmaceutical has been approved to establish the "Henan Provincial Anticholinergic API Engineering Technology Research Center." This center focuses on the application of highly complex chiral synthesis, green catalytic processes, and continuous flow microreactor technology in API production, aiming to reduce production costs, decrease emissions of waste, and improve process safety. Currently, several new processes developed based on this platform have been successfully applied to commercial production lines, achieving a win-win situation of cost reduction, efficiency improvement, and environmental protection.

In addition to meeting its own needs and domestic market demands, PURE Pharmaceutical's API products are exported to many countries and regions, providing a stable and compliant API supply to numerous pharmaceutical companies worldwide. Meanwhile, the company fully leverages its CDMO capabilities to undertake contract manufacturing services for APIs, including process development, technology transfer, custom impurity reference standards, and validation batch production, supporting innovative drug and generic drug companies to accelerate project implementation.

The head of PURE Pharmaceuticals' API division stated, "APIs are the cornerstone of drug quality. We will continue to focus on our two core areas of anticholinergic and emergency care, while expanding into more high-value-added API products. Through continuous technological innovation and a rigorous quality system, we aim to become a long-term trusted partner for global clients in the specialty API field."