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May 29, 2024 · Passing the GMP inspection is an important milestone for subsequent commercialization of domestically produced insulin in the European Union by Gan & Lee's partner Sandoz. It also strengthens the company's global competitiveness and lays a solid foundation for more international business cooperation and market expansion in the future.
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Founded in 1998, Gan & Lee Pharmaceuticals Co., Ltd. is a...
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Dr. Zifei Yuan, CTO of Gan & Lee Pharmaceuticals, said, “After the three insulin products recently submitted in the US FDA, it is another exciting milestone that the MAA submission of Gan & Lee Insulin Glargine biosimilar was positively validated by EMA and entered into scientific evaluation stage.
Founded in 1998, Gan & Lee Pharmaceuticals Co., Ltd. is a pharmaceutical company in China, specializing in the development, production, and commercialization of insulin analogs and medical devices. Headquartered in Beijing, Gan & Lee has an industrial park of about 200,000 square meters. The company has more than 3,000 employees globally.
Orphan drug designation in the European Union (EU) is granted by the European Commission based on a positive opinion issued by the EMA Committee for Orphan Medicinal Products.
In 2018, Gan & Lee Pharmaceuticals signed a commercialization and supply agreement with Sandoz. Under the terms of the agreement, Sandoz has the right to commercialize the three Gan & Lee biosimilars upon approval in specific regions, including the United States, Europe, and other key territories.
Apr 6, 2021 · Orphan drug designation in the European Union (EU) is granted by the European Commission based on a positive opinion issued by the EMA Committee for Orphan Medicinal Products.
Sep 14, 2024 · Gan & Lee Pharmaceuticals (Gan & Lee, Shanghai Stock Exchange: 603087) announced the clinical results from two Phase I trials of the Company's independently developed novel once-weekly...
