Qilu Pharmaceutical Exports Domestically Marketed Ifosfamide for Injection to North America Following Cisplatin

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“Severe shortage of ifosfamide in the Canadian market; it has been listed on the Critical Drug Shortage List. Can Qilu’s product be exported quickly?” Recently, Qilu Pharmaceutical received an “urgent request for assistance” from its Canadian partner. Qilu Pharmaceutical responded immediately, taking only 24 days from the initial submission of documentation to the issuance of the Interim Order Authorization for import and sale by Health Canada.

On June 15, Qilu Pharmaceutical officially shipped its Ifosfamide for Injection. This marks the first time a domestically marketed product has been supplied to Canada to address drug shortages, and represents Qilu’s second export of Chinese-labeled, domestically marketed products to the North American market, following the special export of its Cisplatin Injection to the United States in 2023.

Li Shan, Secretary of the Party Committee of the Haikou High-Tech Industrial Development Zone Administrative Committee; Huang Yi, Researcher of the Haikou Municipal Bureau of Science, Industry and Information Technology; Lu Hong, Secretary-General of the Hainan Pharmaceutical Industry Association; Liu Wenmin, Chairman of Qilu Pharmaceutical (Hainan) Co., Ltd.; Sun Yanyan, General Manager of Qilu Pharmaceutical (Hainan) Co., Ltd.; and Zhang Guiting, Executive Dean of the Hainan Branch of Qilu Institute of Pharmaceutical Research, attended the shipping ceremony.

Why was Health Canada able to authorize importation in such a short period of time?

Ifosfamide for Injection is a commonly used chemotherapeutic agent in clinical oncology. Currently, a supply shortage of this product in the Canadian market is placing significant pressure on clinical diagnosis and treatment services, thereby compromising the assurance of patients’ medication needs., Health Canada has therefore established an expedited access pathway for shortage medications, globally selecting compliant, high-quality pharmaceutical products to safeguard public health and safety.

Qilu Pharmaceutical has been deeply rooted in Canada for many years, with multiple formulated products selling well in the market. The company has established a quality management and control system aligned with international standards, forming a comprehensive management system covering the entire lifecycle of pharmaceuticals. It implements full-staff, comprehensive, and whole-process quality control, earning the trust of the international market. Qilu Pharmaceutical’s Ifosfamide for Injection (Lumai^®) Approved for marketing in China in 2009, its clinical efficacy has been widely recognized, and its robust quality prompted Canadian authorities to fast-track its approval.

How Did Qilu Pharmaceutical Secure Special Import Approval at the Fastest Speed?

Upon learning of the drug shortage in Canada, Qilu Pharmaceutical coordinated across multiple departments to efficiently manage documentation preparation, qualification processing, and compliance verification. The company completed the preparation and submission of the full set of application materials within just one day, and subsequently provided prompt, comprehensive, and well-reasoned responses to questions and additional information requests raised by Health Canada.

Why is this export significant?

When Canadian physicians use Qilu Pharmaceutical’s Ifosfamide for Injection in clinical practice, they will encounter packaging and labels entirely in Chinese. This batch of export products consists of domestically manufactured finished pharmaceuticals produced on local production lines, requiring no relabeling or standard modifications, and is granted direct access to the Canadian market.

Some people believe that domestic pharmaceutical companies adhere to a “dual standard” of stringent requirements for exports and lenient ones for domestic sales. However, at Qilu Pharmaceutical, there is only one unified high standard. The company upholds its commitment to “shared production lines and global quality consistency,” ensuring that products for both domestic and international markets are manufactured on the same production lines and adhere to the same quality standards. Cisplatin Injection and Ifosfamide for Injection, packaged entirely in Chinese, have been exported to the United States and Canada respectively without the need for on-site inspections. This demonstrates that Qilu’s domestically marketed products are fully aligned with international standards and can simultaneously meet the regulatory requirements of regulated markets. It also reflects the trust placed by European and American drug regulatory authorities in China’s pharmaceutical regulatory system and Qilu Pharmaceutical’s quality management.

Which products has Qilu Pharmaceutical strategically focused on in the Canadian market?

Canada is one of the top ten pharmaceutical consumer markets globally, holding immense potential. Currently, Qilu Pharmaceutical has exported 10 formulated products.Canada, primarily covering areas such as anti-tumor, anti-infective, and ophthalmology, in addition to the current export ofIfosfamide for Injection, also including Octreotide Acetate Microspheres for Injection,Oxaliplatin Injection,Irinotecan Hydrochloride Injection,Ranibizumab Injection,Piperacillin Sodium and Tazobactam Sodium for Injection, Cefepime for Injection, and other products have earned a strong reputation thanks to their consistent quality. Additionally, several other products have been submitted for market approval.

Five products have been listed as FDA reference listed drugs, 12 products have been selected by the United States Pharmacopeia (USP) as USP standards, 41 formulations have been exported to the United States, 19 formulations to Europe, and five formulations to Japan; two biologics have been approved for marketing in the UK. In addition to Canada, Qilu Pharmaceutical's product quality has also gained high recognition from regulatory markets including the United States, the European Union, the UK, and Japan. Currently, Qilu Pharmaceutical’s products are sold to more than 110 countries and regions worldwide, benefiting approximately 1.5 billion people annually.

In the future, Qilu Pharmaceutical will continue to center on innovation and base its operations on quality, leveraging the advantages of its full-chain system encompassing R&D, manufacturing, quality control, and commercialization, to provide global patients with greater access to high-quality medicines.

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