2010-06-11
Small
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ConnectType:
T - Technology & Patents
Industry:
Pharmaceuticals and Chemical Intermediates
Country / Region:
China
Company Type:
State-controlled enterpriseListed company
Registered Capital:
RMB 123,428.2054 million
Company Capability: Process Technology Development
Wuhan Zhongyuan Ruidi Biopharmaceutical Co., Ltd. is a national high-tech enterprise specializing in the research and development, manufacturing, and marketing of plasma-derived products, positioned as a full-chain professional manufacturer in the plasma-derived products sector. Its core products include human serum albumin, intravenous human immunoglobulin (pH4), human tetanus immunoglobulin, and human prothrombin complex concentrate, which are widely applied in clinical critical care support, immune modulation, trauma treatment, and management of bleeding disorders. Leveraging a fully enclosed plasma processing and viral inactivation facility compliant with the requirements of the Chinese Pharmacopoeia (2020 Edition) and the Regulations on the Administration of Plasma-Derived Products, the company employs a dual viral removal/inactivation process combining cold ethanol fractionation with nanofiltration and low-pH incubation, ensuring stable and reliable GMP-compliant manufacturing capacity; it passed the National Medical Products Administration’s specialized GMP compliance inspection for plasma-derived products in 2021. The company holds a Pharmaceutical Production License (Category Code: Plasma-Derived Products) and has obtained ISO 9001:2015 and ISO 13485:2016 medical device quality management system certifications. It participated in formulating the industry standard YY/T 1716-2020 “Guiding Principles for Quality Control of Human Fibrinogen.” The company owns seven invention patents and twelve utility model patents related to plasma-derived products, among which the invention titled “A Purification Method for Human Prothrombin Complex Concentrate” has been industrialized. Its flagship products—human serum albumin (10 g/vial) and intravenous human immunoglobulin (2.5 g/vial)—are both included in the “National Essential Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance Drug List (2024 Edition).” Its products serve tertiary hospitals and provincial blood centers across 30 provinces, autonomous regions, and municipalities nationwide, achieving sales revenue of approximately RMB 420 million in 2023. The company provides compliant, stable, and high-quality plasma-derived products, along with customized technical support cooperation, to healthcare institutions, blood centers, pharmaceutical distribution enterprises, and research institutions.
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