Inpacpen DCP®, a pen injector made in China, has obtained FDA approval in the United States, ushering in a new era for drug-device combination products going global!

June 10, 2026  Source: drugdu 28

Recently , a strategic partner of Shanghai Newyao Baike Medical Technology Co., Ltd. (Shanghai Newyao Baike Medical Technology Co., Ltd.) received formal approval from the U.S. Food and Drug Administration (FDA) for its Inpacpen DCP® disposable adjustable-dose cartridge injection pen, successfully approved for use in its liraglutide injection! This is the first drug-device combination product approved by the FDA using a pen syringe manufactured in China, marking a historic step for China's high-end drug delivery devices in entering the international market with the highest regulatory standards.

It is also the company's third product to receive approval in the U.S. market, following the Safetis® needle protector and the InpacJector® Luer pre-filled syringe (COP)!"/A historic breakthrough in China's drug-medicine combination products

Liraglutide, a blockbuster GLP-1 drug, has long relied on European and American suppliers for its delivery devices. This approval signifies that Chinese-made pen injectors have officially entered the world's most stringent pharmaceutical market, becoming an integral core component of drug-device combination products and a crucial part of FDA approval.

After nearly two years, it has passed rigorous reviews and gained recognition from major global regulatory agencies, and for the first time, it has deeply embedded itself in the global high-standard drug supply chain as a "core supplier."
Fully automated intelligent manufacturing factory

To ensure global delivery capabilities, the company has built a 25,000㎡ fully automated intelligent manufacturing plant, including a 9,300㎡ self-injection pen production workshop, which has been recognized as a "Shanghai Municipal-level Intelligent Factory." The fully automated production lines, AI visual quality inspection, and deep integration of ERP/MES information systems have enabled unmanned intelligent management throughout the entire process from injection molding and assembly to packaging. The company's overall annual production capacity of self-injection pens reaches 100 million units, and it is continuously supplying high-quality Chinese-made injection pens to the global market.

https://news.yaozh.com/archive/48293.html

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