Qilu Pharmaceutical Ships Two New Formulations to the U.S., Bringing Total U.S.-Approved Products to 37

Recently, two formulation products of Qilu Pharmaceutical – Cefaroline Mesylate for Injection and Ganirelix Acetate Injection – have simultaneously departed from Qilu High-tech Production Base and the Biomedical Industrial Park, respectively, officially heading to the U.S. market. This marks the second and third products exported to the U.S. by Qilu Pharmaceutical this year, following Nicardipine Hydrochloride Injection, showcasing breakthrough achievements in both "patent challenge for first-to-file generics" and the "dual filing and dual approval in China and the U.S." domains. These developments bring the total number of Qilu Pharmaceutical’s formulation products exported to the U.S. to 37.

Although the two products have different therapeutic areas and breakthrough paths, the foundation of their successful international expansion lies in Qilu Pharmaceutical's R&D, production, and quality management systems, which are fully aligned with international standards. Qilu Pharmaceutical has always adhered to the quality commitment of "concurrent production, global consistency," implementing full lifecycle quality management for its pharmaceuticals. By introducing advanced international production technologies and intelligent equipment, the company has built a world-class formulation smart manufacturing platform, ensuring the utmost stability in product quality and high efficiency in large-scale production through a high degree of automation, digitalization, and intelligence. Currently, Qilu Pharmaceutical has passed system certifications from all major regulatory markets worldwide and continues to expand into high-end international markets.

To date, the products of Qilu Pharmaceutical have been exported to more than 100 countries and regions worldwide, benefiting approximately 1.5 billion patients every year. For many years, it has remained the only pharmaceutical company in China that simultaneously exports formulations to regulated markets in Europe, the United States, the United Kingdom, Japan, Australia, and Canada, with 38 products ranking first in local market share. In the future, Qilu Pharmaceutical will continue to adhere to its dual-driven strategy of innovation and internationalization, focusing on clinical needs. Relying on a robust R&D system and intelligent manufacturing platform, the company will steadily advance its international layout, promoting more high-quality and accessible medicines to serve patients globally.

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