Jiangsu Gangan —A Subsidiary of Gan & Lee Receives FDA Clearance for Insulin Injection Pen Needle-Gan & Lee Pharmaceutical

Company News

Jiangsu Gangan —A Subsidiary of Gan & Lee Receives FDA Clearance for Insulin Injection Pen Needle

  • Time: 2020-10-10 10:32:05
  • Click Rate: 6959

Beijing, China/Bridgewater, New Jersey U.S, September, 2020 Gangan Medical Technology Jiangsu Co., Ltd (hereinafter referred to as Jiangsu Gangan) — a wholly-owned subsidiary of Gan & Lee Pharmaceuticals (hereinafter referred to as Gan & Lee, stock code: 603087.SH) has successfully received (510(k) number: K192464) clearance from the U.S. Food and Drug Administration (FDA) for the Injection Pen Needle. Jiangsu Gangan plans to submit the Establishment Registration and Device Listing to FDA for an opportunity to be marketed  in the U.S following 510(k) clearance. 

The Injection Pen Needle, (single-use disposable) is designed for use with Pen Injectors for subcutaneous injection of a desired dose of drugs approved for delivery using a pen needle. The injection pen needle is offered in a variety of different sizes. The needle was evaluated for substantially equivalent endpoints based upon the FDA guidance on the Use of International Standards ISO 10993-1. Jiangsu Gangan is committed to provide safe and effective products.


Picture: The FDA’ s 510(k) premarket notification for Insulin Pen Needle


About 510(k) Clearances

510(k) is the technical dossier required by the US Food and Drug Administration (FDA) to sell a medium-risk medical device or IVD in the United States. It is formally called a Pre-market Notification. A 510(k) contains detailed technical, safety, and performance information about a medical device. The documentation must demonstrate the device in question is "substantially equivalent" to a predicate device (i.e. a product already cleared for sale in the US). The FDA must review the 510(k) and "clear" your device before you can legally sell or distribute it in the United States.

About Jiangsu Gangan

Founded in Taizhou Jiangsu, China in 2017, Gangan Medical Technology Jiangsu Co., Ltd (hereinafter referred to as Jiangsu Gangan) is a wholly-owned subsidiary of Beijing Gangan Technology Co., Ltd (hereinafter referred to as Beijing Gangan), of which main business is product R&D, design, as well as new technology development of accessory medical devices for diabetes treatment. The current main products are insulin injection pen, glucose monitoring and test strips, prefilled injection pen (disposable) and disposable insulin pen needle. Some products have obtained domestic medical device registration certificates and have been approved for marketing in Europe, Southeast Asia, South America and other countries and regions.

Jiangsu Gangan is committed to finding solutions for patient with diabetes. The company is seeking scientific solutions for diabetes care with their research and development. We are investigating new-generation glucose monitoring and insulin injection systems that incorporate cloud data management with a dedicated goal to meet patient needs.

About Gan & Lee

Gan & Lee successfully developed the first Chinese domestic biosynthetic human insulin. At present, the company has four recombinant insulin analogs commercialized in China including long-acting glargine (Basalin®), fast-acting lispro (Prandilin®), mixed protamine zinc lispro injection (25R) (Prandilin®25) and fast-acting aspart, as well as prefilled injection pen (disposable) and insulin injection pen (reusable) commercialized in China.

In the future, Gan & Lee strives to achieve a comprehensive coverage in the field of diabetes diagnosis and treatment. Moving forward to advance Gan & Lee’s goal of becoming a world-class pharmaceutical company, we will also take an active part in investigating new chemical entities and biologics to treat cardiovascular disease, metabolic diseases, cancer, and diseases in other therapeutic areas.