Quality Department

This year, 21 products were added under the B certificate, and 3 products with 4 product numbers passed GMP compliance inspections and obtained inspection notices. Over 230 quality system documents were created and revised. More than 2,000 external project documents were approved and feedbacked. 22 drug (Quality Agreements for Outsourced Production) were signed. 76 material suppliers were audited (including 35 on-site audits). 15 audits were conducted on outsourced production companies, 3 audits on outsourced transportation companies, 8 audits on outsourced inspection companies, and 8 on-site supervision batches for the research varieties and 6 batches for the commercial production of market-approved varieties (with 3 additional batches ongoing). 107 training sessions were completed, and assistance was provided in the completion of 4 registration inspections and 7 product registration sampling. 6 external sterile drug contract manufacturing companies participated in the bacterial endotoxin testing capability assessment organized by the Shandong Province, and all received satisfactory results.

Pharmacovigilance Department

Revised and improved more than 10 pharmacovigilance management documents, and invited various departments to review the pharmacovigilance-related work processes and documents. Conducted a level III emergency drill using sodium penicillin injection as a case study for a sudden drug event. Performed post-market risk management analysis for the risk levels of our marketed products, and promptly handled adverse drug reactions for the products we hold.

Sales Department

In 2024, Ruzhi's listed product, injectable Clonixin, gained market access in 13 provinces, while injectable Penicillin Sodium gained market access in 19 provinces. The market access work for injectable Cefoperazone Sodium is still ongoing. Among them, the total sales volume of injectable Clonixin reached 220,000 bottles.

Production Department

Highlights Summary: In 2024, the Production Department focused on quality and management, further optimizing work processes and refining job responsibilities to ensure efficient and stable production. The department completed GMP inspections for 3 marketed products and handled various license extension and registration verification tasks, achieving a 100% pass rate. In terms of market supply assurance, the department carried out production scheduling for three marketed products, completing a total of 6 batches, approximately 300,000 units of marketed products, with a 100% market supply rate. In 2025, the Production Technology Department will continue to strive for excellence, face challenges head-on, and perform its duties to ensure continued market supply.

Year-End Work Summary

The main focus of Ruzhi Biomed's work in 2024 was on the Marketing Authorization Holder (MAH). This year, the company completed the B-license expansion of 21 product varieties, passed the GMP compliance inspections for three products—Injectable Penicillin Sodium, Injectable Lornoxicam, and Injectable Cefoperazone Sodium—and obtained the inspection notice for four product licenses. The company successfully hosted over 10 inspections from provincial and municipal bureaus. Production scheduling was carried out for three marketed products, with a 100% market supply rate for Injectable Lornoxicam. The pharmacovigilance work was conducted in an orderly manner, while several research and development projects were also undertaken. Additionally, the company assisted Southwest Pharmaceuticals in obtaining the production license for Injectable Benzylpenicillin Sodium, filed for the registration of five projects, and submitted supplementary research for two. In 2025, Ruzhi Biomed will continue to push forward, face challenges head-on, strengthen its MAH work, ensure the effective and efficient operation of its quality management system, and maintain market supply stability!

Ruzhi Biomed located in the Modern Pharmaceutical Port of Heze City, Shandong Province, was established in December 2021. It is a CRO company founded by renowned industry experts, specializing in providing pharmaceutical R&D technology services.

The company’s main business includes the research and development of generic drugs, consistency evaluation technical services, and MAH (Marketing Authorization Holder) cooperation. Ruzhi Biomed relies on the services of Chiheal (Shandong) Pharma Co., Ltd., which provides one-stop CDMO services, creating a CXO+MAH cooperation platform. Ruzhi Biomed functions both as an R&D company and as an MAH holder. In recent years, it has collaborated with several well-known companies, such as North China Pharmaceutical, Sanjiu Pharmaceutical, and Southwest Pharmaceuticals, on technological development or has obtained production licenses.

30% of the employees hold master's degrees, and 95% have a bachelor's degree or higher. With its well-established R&D quality management system and MAH quality assurance system, Ruzhi Biomed is steadily growing within the CXO and MAH platforms.