2019-08-05
Medium-sized
0personInquired
0personFavorited
ConnectType:
T - Technology & Patents
Industry:
Pharmaceuticals and Chemical IntermediatesFine Chemical Manufacturing
Country / Region:
China
Company Type:
Listed company
Registered Capital:
RMB 98 million
Company Capability: Process Technology Development、Chemical Technology & Patents、Technology Transfer
Inner Mongolia Anzhou Pharmaceutical Co., Ltd. is a high-tech enterprise specializing in the research and development, production, and sales of active pharmaceutical ingredients (APIs) and pharmaceutical intermediates, with a strategic focus on niche segments including quinolone- and catecholamine-based APIs. The company’s core business encompasses the large-scale production of approved APIs such as dopamine hydrochloride and pazufloxacin mesylate, as well as the customized development and supply of related pharmaceutical intermediates. Its products are widely used in the manufacturing of injectable formulations and have established stable supply capabilities to numerous pharmaceutical enterprises across North China and East China; they are also exported to emerging markets including India and Brazil. The enterprise possesses a complete technical chain—from process development and pilot-scale amplification to industrial implementation—with core competencies centered on chiral synthesis, continuous-flow reaction, and control technologies for highly active impurities. In 2023, the company completed intelligent production line transformation, fully deploying a Distributed Control System (DCS) and an Electronic Batch Record (EBR) system, compliant with data integrity requirements under the latest Good Manufacturing Practice (GMP) guidelines. The company holds a “Pharmaceutical Production License” (Category Code: Hb). Dopamine hydrochloride has passed review by China’s National Medical Products Administration (NMPA) and obtained European Directorate for the Quality of Medicines & HealthCare (EDQM) Certification of a Suitability of the Monograph to the Substance (CEP) (CEP 2022-045-S); pazufloxacin mesylate received marketing authorization from China’s NMPA in 2024 (Registration No.: H20240012). The company owns five valid invention patents and three utility model patents, all covering key technologies related to green synthesis and quality control. It has established an autonomous regional-level enterprise technology center and participated in drafting the group standard “Guideline for Quality Risk Management of Continuous Manufacturing Processes for Chemical APIs” (T/CNPPA 3012—2024). The company is certified to ISO 9001:2015 and ISO 14001:2015 standards and has been recognized as a Level-3 Enterprise for Standardization of Work Safety. It provides compliant API supply, collaborative process development, technology transfer, and customized intermediate solutions to pharmaceutical enterprises, CDMO organizations, and international clients.
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