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Recently, Beijing Yiling Bio-engineering Technology Co., Ltd. (Beijing Yiling Bio), a wholly-owned subsidiary of Yiling Pharmaceutical Ltd., has successfully passed an unannounced facility inspection conducted by the U.S. Food and Drug Administration (FDA). This represents another internationally recognized quality accreditation following the company’s first FDA inspection clearance in 2022. As the national pharmaceutical regulatory authority of the United States, the FDA is among the world’s most authoritative and influential drug regulators. Its inspection standards are rigorous, comprehensive and highly detailed, covering the full lifecycle of pharmaceuticals, including research and development, manufacturing, quality control, warehousing and distribution. Successfully passing this…

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  Recently, both Tinidazole tablets and Gliquidone tablets from Yiling Group have passed generic quality consistency evaluation, this means currently Yiling Group have 11 products passed this consistency evaluation, which indicates drug quality is not lower than branded drug and have equivalent efficacy to branded drug. When it comes to Yiling Group, we are familiar with Lianhua Qingwen, a traditional Chinese medicine(TCM) that plays an important role in COVID-19 in the past two years.But in fact, TCM is only one of Yiling’s three major business sectors.In recent years, Yiling Group has rapidly developed TCM, meanwhile actively laid out chemical&bio-medicines…

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  The goal of the first step strategic planning of chemical&bio-medicines sector of Yiling Group is to “Cutting-in by Contract Manufacturing”, that is building production workshops and quality management system in accordance with EU and US GMP standards,to carry out manufacture and export of Finished Drug Products for domestic and international enterprises, including pharmaceutical R&D institutions, large pharmaceutical enterprises and pharmaceutical commercial companies (MAH holders). Yiling Pharmaceutical Ltd. (hereinafter referred to as”Yiling Pharma”) is a wholly owned subsidiary of Shijiazhuang Yiling Pharmaceutical Co. Ltd.(hereinafter referred to as”Yiling Group”), undertakes the development business of the international and domestic markets of…

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  The second target strategic planning of Yiling pharma is “international and domestic dual registration of generic drugs”. The goal of the second stage is to designate generic drugs with large market capacity, growth potential and high technical threshold, to finishe R&D and registration in domestic and high-end international markets. While achieving the sales in international markets such as Europe and US, the domestic varieties sales activities shall be carried out by using the throughout marketing network in China. At present, the second strategic plan is developing in depth. For the US market, Yiling Pharma has 13 ANDA products…

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  The third target of development strategy is, through the R&D of innovative drugs, then conducting domestic and international registration and patent authorization in foreign markets, to make Yiling Pharma be a large multinational pharmaceutical enterprise with the core competitiveness of innovative drugs and advanced  technology platform ,  At present, 27 products have been approved by China NMPA and US FDA, including 11 products passed generic quality consistency evaluation. In terms of R&D, Yiling Group attaches great importance to independent R&D activity of innovative chemical drugs, and will continue to speed up screening and approval of new projects, enrich…

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