Qilu Pharmaceutical's 1st FDA-approved medication exported to US
A truck loaded with Qilu Pharmaceutical's Cisplatin Injection departs for the United States. [Photo/Shandian News]
A truck loaded with Qilu Pharmaceutical's Cisplatin Injection departed on June 18, marking the first export of the product to the United States since its official approval.
This medication, praised by Chinese-American doctors as the "light of Chinese medicine", was urgently approved for export by the US Food and Drug Administration (FDA) to alleviate a local shortage of clinical drugs. The drug is Qilu Pharmaceutical's 27th formulation product to be exported to the US.
On May 23, 2023, to address the shortage of Cisplatin Injection in the US, the FDA initiated an expedited approval process, allowing Qilu Pharmaceutical to temporarily import its domestic brand of Cisplatin Injection. This marked the first time a Chinese pharmaceutical company has helped alleviate a drug shortage in the US market through the direct export of a product sold in China.
The Cisplatin Injection was officially approved through the FDA's accelerated review process on May 10, taking only nine months from start to finish, significantly shorter than the usual registration time. This highlights Qilu Pharmaceutical's strong research capabilities and high product quality.
Currently, nearly half of Qilu Pharmaceutical's products sold in the US hold the top market position in sales.
Qilu Pharmaceutical is the first Chinese company to obtain sterile product certifications from the FDA, the European Directorate for the Quality of Medicines and Healthcare, and the United Kingdom's Medicines and Healthcare Products Regulatory Agency, and is the only domestic enterprise exporting formulations to regulated markets in Europe, the US, the UK, Japan, Canada, and Australia.
With its top-quality products and reliable supply capabilities, Qilu Pharmaceutical has stood out in the market, consistently exporting to over 100 countries and regions worldwide. Approximately 40 of its products hold the top market share globally or in the countries where they are sold, benefiting around 1.5 billion patients.
