Qilu Pharmaceutical Launches First Ophthalmic Product Export to the U.S. Market

Good rain knows its time; it falls when spring arrives. On March 18, a spring rain arrived as expected, adding a special touch to the internationalization process of Qilu Pharmaceutical's preparations. At the Jinan High-tech Production Base, Qilu Pharmaceutical's ophthalmic products were officially shipped for export. This marks the first ophthalmic product from Qilu Pharmaceutical to be exported to the United States, and it is also the 39th product manufactured by the company to enter the U.S. market.

The product project was conducted in full compliance with U.S. cGMP standards throughout the research and validation process. After thousands of trials, it achieved breakthroughs in key technological bottlenecks such as emulsification stability and sterile assurance. Ultimately, with a complete data chain and reliable quality system, it successfully passed the rigorous evaluation by the U.S. FDA, establishing a stable and controllable large-scale production system. On January 21, 2026, the product officially received FDA approval; in February 2026, the first three batches of commercialized products were successfully produced and passed all quality inspections, achieving immediate mass production upon approval and meeting standards upon mass production.

AsChina MedicineAs a leading enterprise in the industry, Qilu Pharmaceutical Co., Ltd. has always adhered to a dual-driven strategy of innovation and internationalization, continuously expanding its presence in the global pharmaceutical market. Relying on a world-class quality management system that fully aligns with international standards, the company exports multi-formulation and multi-therapeutic area products, including injectables, oral preparations, and ophthalmic formulations, to over 110 countries and regions worldwide. Dozens of its formulations have successfully entered high-end regulated markets such as the U.S., EU, and Japan. To date, Qilu Pharmaceutical is the only pharmaceutical company in China that simultaneously exports formulations to the regulated markets of Europe, the U.S., the UK, Japan, Australia, and Canada. The company annually exports approximately 200 million vials of injectables, with 40 products ranking among the top in overseas market share, achieving an export target of $1.11 billion by 2025.

In the future, Qilu Pharmaceutical will continue to uphold the mission of "expressing our love through technology," focusing on global patients' health needs. It will continuously expand the breadth and depth of its product pipeline, consistently launching more "Made in China" medicines that are accessible, affordable, and effective for patients worldwide. With a more open posture, it will integrate into the global pharmaceutical innovation system, empower high-quality development through technological innovation, serve the global market with "Qilu quality," and contribute greater efforts to safeguarding human life and health.