
2011-04-11
Medium-sized
0 Inquired
0 Favorited
ConnectService Type:
T - Technology & Patents
Industry:
Pharmaceuticals and Chemical IntermediatesChemical Engineering Technology Research and Development and Process Package
Country / Region:
China
Company Type:
Private enterprise
Registered Capital:
50 million RMB
corporate capability: Full-Cycle Chemical Project Services、Process Technology Development、Chemical Technology & Patents、Process Package Design、Design Optimization、Chemical Engineering Design、Technology Transfer
Shandong Luoxin Pharmaceutical Group Hengxin Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Shandong Luoxin Pharmaceutical Group Co., Ltd. (002793.SZ), engaged in the production of active pharmaceutical ingredients (APIs) and pharmaceutical intermediates. The company is positioned as a GMP-compliant API manufacturing platform integrating R&D, production, quality management, and compliant export operations, supporting the Group’s strategies of “API + formulation integration” and “green intelligent manufacturing upgrade.” Its core product portfolio comprises over ten API varieties, primarily in the anti-infective category (e.g., sodium cefuroxime, cefixime, azithromycin, clarithromycin) and cardiovascular therapeutics. Products mainly secure the internal formulation supply chain of Luoxin Pharmaceutical and are supplied to compliant domestic and international customers; exports cover India, Southeast Asia, the Middle East, Latin America, and other regions. The company maintains a quality management system compliant with ICH Q7 requirements and has completed API registration with China’s National Medical Products Administration (NMPA) (Registration No. Y20220001289, etc.), passed the U.S. FDA cGMP on-site inspection (cephalosporin API workshop inspection completed in June 2023), and obtained multiple European Directorate for the Quality of Medicines & HealthCare (EDQM) Certificates of a Suitability of the Monograph to the Composition of the Substance (CEPs). It also holds ISO 9001, ISO 14001, and ISO 45001 certifications and was designated in 2022 as a Shandong Province “Specialized, Refined, Distinctive, and Innovative” (SRDI) small- and medium-sized enterprise. Technologically, the company has established an intelligent continuous manufacturing line for cephalosporin APIs (commissioned in 2024) and continues advancing green synthetic process optimization and continuous flow technology applications; its project titled “Key Green Synthesis Technologies and Industrialization of Cephalosporin Antibiotics,” supported by these achievements, received the Second Prize of the 2023 Shandong Provincial Science and Technology Progress Award (Luoxin Pharmaceutical being the primary completing entity). Collaboration opportunities include customized API development and large-scale supply, joint green process optimization, international regulatory registration support, and contract manufacturing services compliant with cGMP/CEP/FDA standards.
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