Dalian Wonful Pharmaceutical Co,Ltd., established in 2003 and located in the Jinpu New Area of Dalian City, Liaoning Province, is a national high-tech enterprise specializing in the research, development, manufacturing, and sales of active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs). The company is currently in a stable, scaled-up development phase. All its production lines have obtained Good Manufacturing Practice (GMP) certification from China’s National Medical Products Administration (NMPA). Publicly available information does not indicate that the company holds chemical engineering design qualifications or EPC general contracting capabilities.  

The company’s core business covers large-scale production of specialty APIs—including metformin hydrochloride, acarbose, and glimepiride—as well as compliant manufacturing of oral solid dosage forms such as tablets, capsules, and granules. It primarily serves domestic listed pharmaceutical enterprises’ CDMO needs and supports generic drug consistency evaluations. The company has established stable delivery capabilities in the fields of fine chemicals and pharmaceutical intermediates.  

Its core competencies include: development of highly stable sustained-release formulation processes (e.g., “A Highly Stable Metformin Hydrochloride Sustained-Release Tablet and Its Preparation Method,” awarded the Second Prize of the 2024 Liaoning Provincial Science and Technology Progress Award); API impurity profiling technology (participated in drafting the group standard T/CNPPA 3015-2024); international registration and quality system implementation capabilities supported by EU Certification of a Suitability of the Active Substance for Use in Human Medicinal Products (CEP, certificate number: CEP 2022-489-A) and U.S. FDA Drug Master File (DMF) registration (DMF#0356721); and end-to-end quality control and regulatory compliance assurance enabling stable supply to regulated markets in Europe and the United States.  

The company holds a “Pharmaceutical Production License” (Liaoning No. 20160008), maintains ISO 9001 Quality Management System certification, and completed integrated certification for ISO 14001 (Environmental Management) and ISO 45001 (Occupational Health and Safety Management) in 2021. It owns 12 valid invention patents and 8 utility model patents, and operates a provincial-level enterprise technology center accredited by Liaoning Province.  

Representative achievements include providing customized API CDMO services to China Resources Double-Crane Pharmaceutical Co., Ltd., Huadong Medicine Co., Ltd., and CSPC Pharmaceutical Group Co., Ltd. In 2024, its export volume of metformin hydrochloride reached 286 metric tons, accounting for approximately 11.3% of China’s total exports of the same product. Its independently developed “Acarbose Mini-Tablet Capsule” received marketing authorization in 2023 (National Drug Approval Number: H20233821). Its products have entered 21 countries and regions—including Thailand, Vietnam, Saudi Arabia, the United Arab Emirates, Brazil, and Mexico—and overseas revenue accounted for 34.6% of total revenue in 2025. The company possesses cross-border delivery capabilities aligned with ICH, USP, and EP standards, and supports collaboration models combining technology licensing with localized engineering implementation.