As the saying goes, "Good rain knows its season, and falls when spring arrives." On March 18th, a spring rain arrived as expected, adding a unique touch to Qilu Pharmaceutical's internationalization process. At its Jinan High-tech Production Base, Qilu Pharmaceutical's cyclosporine ophthalmic emulsion was officially exported and shipped. This is Qilu Pharmaceutical's first ophthalmic preparation exported to the United States, and also the company's 39th pharmaceutical preparation to enter the US market.

Cyclosporine ophthalmic emulsion is a calcineurin inhibitor and immunosuppressant. It is indicated for patients with dry eye syndrome whose tear production is suppressed due to ocular inflammation such as keratoconjunctivitis sicca, as well as for patients who have not observed increased tear secretion despite the use of topical anti-inflammatory drugs or punctal occlusion. This product is a complex emulsion ophthalmic medication, composed of multiple components including an aqueous phase and an oil phase, making its formulation and manufacturing process highly complex and subject to stringent quality requirements.

The project adhered to US cGMP standards throughout its research and validation process, undergoing thousands of trials to overcome key technological bottlenecks such as formulation optimization, emulsification stabilization, and aseptic assurance. Ultimately, it passed the stringent review of the US FDA with a complete data chain and a reliable quality system, 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 commercially available products successfully rolled off the production line and passed all quality inspections, achieving mass production immediately upon approval and compliance with standards upon mass production.

As a leading enterprise in China's pharmaceutical industry, Qilu Pharmaceutical has always adhered to a dual-drive strategy of innovation and internationalization, continuously cultivating the global pharmaceutical market. Relying on a world-class quality management system fully aligned with international standards, it has achieved exports of multi-dosage forms and therapeutic areas, including injectables, oral preparations, and ophthalmic formulations, to more than 110 countries and regions worldwide. Dozens of its formulations have successfully entered high-end regulatory markets such as the United States, the European Union, and Japan. Currently, the company is the only domestic pharmaceutical enterprise simultaneously exporting formulations to regulatory markets in Europe, the United States, the United Kingdom, Japan, Australia, and Canada, exporting approximately 200 million vials of injectables annually. Forty of its products hold the number one market share overseas, and exports are projected to reach US$1.11 billion by 2025.

In the future, Qilu Pharmaceutical will continue to uphold its mission of "expressing our love through technology," guided by the health needs of global patients, continuously expanding the breadth and depth of its product pipeline, and launching more "Made in China" drugs that are accessible, affordable, and effective for global patients. With a more open attitude, Qilu Pharmaceutical will integrate into the global pharmaceutical innovation system, empower high-quality development through technological innovation, serve the global market with "Qilu quality," and contribute even more to safeguarding human health.

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