Dalian Runhui Pharmaceutical Co., Ltd., located in the Jinpu New Area of Dalian City, Liaoning Province, is a high-tech manufacturing enterprise specializing in the research and development, production, and sales of chemical pharmaceuticals. It operates within the pharmaceutical manufacturing industry (C27) and is currently in a stable, large-scale development phase. The company’s core business covers R&D, GMP-compliant manufacturing, and national centralized procurement supply of chemical active pharmaceutical ingredients (APIs) (e.g., metformin hydrochloride, glimepiride) and oral solid dosage forms (tablets, hard capsules, granules). Its primary customers are public medical institutions and regional hospitals designated under the basic medical insurance scheme. Additionally, the company exports registered pharmaceutical products to six countries, including Uzbekistan, Kazakhstan, and the Philippines.  

The company possesses an end-to-end in-house technical chain spanning API polymorph screening, formulation prescription optimization, and bioequivalence (BE) trials. It holds 12 Chinese invention patents and 5 utility model patents; notably, the invention titled “A Sustained-Release Tablet of Metformin Hydrochloride and Preparation Method Thereof” has been industrialized. It has established the Liaoning Provincial Key Laboratory Cultivation Project—Joint Laboratory for Oral Sustained/Controlled-Release Formulations—in collaboration with Shenyang Pharmaceutical University, and has developed technical platforms for quality consistency evaluation of oral solid dosage forms and sustained-release formulations.  

The company holds a Drug Manufacturing License (Liaoning No. 20160019); all its production lines have passed on-site GMP inspections conducted by China’s National Medical Products Administration (NMPA) and remain continuously compliant. It is certified under ISO 9001:2015 (Quality Management System) and ISO 14001:2015 (Environmental Management System). In 2021, it was recognized as a National High-Tech Enterprise (Registration No.: GR202121000287).  

Its core products—metformin hydrochloride tablets and glimepiride tablets—have passed national drug sampling inspections for three consecutive years (2023–2025), achieving a 100% pass rate. Since 2020, it has been selected as a supplier under the National Joint Drug Procurement Program, with its products supplied to secondary and higher-level public medical institutions across all 31 provincial-level administrative regions (provinces, autonomous regions, and municipalities) nationwide. In 2024, its metformin hydrochloride tablets captured an 8.3% market share in domestic hospital-based sales channels.  

Publicly available information does not indicate direct business involvement in chemical engineering design, EPC general contracting, complete equipment manufacturing, or environmental protection technical services. Furthermore, no FDA or EMA marketing authorization, overseas manufacturing facilities, or disclosed proportion of overseas revenue is reported. Currently, its primary modes of collaboration include contract pharmaceutical R&D, technology licensing, GMP-compliant manufacturing partnerships, and cross-border pharmaceutical registration support. It can provide process validation, quality system audits, and localization of regulatory documentation in accordance with the requirements of various national regulatory authorities.