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Global Expansion | Tonghua Dongbao's Liraglutide Injection Passes the On-Site GMP Audit by ANVISA
Date：2025-11-26
Author：东宝
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Recently, a liraglutide injection, developed by Tonghua Dongbao Pharmaceutical Co., Ltd. ("Tonghua Dongbao" or the "Company") and its partner, Kexing Biopharm Co., Ltd. ("Kexing Biopharm"), has passed an on-site Good Manufacturing Practice (GMP) audit conducted by the Brazilian Health Regulatory Agency (ANVISA), a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S), with zero deficiencies. This audit is one of the key review steps required before the product can enter the Brazilian market.
Based on its positive outlook for emerging markets, in December 2022, the Company and Kexing Biopharm signed an exclusive licensing agreement, granting Kexing Biopharm the exclusive rights to sell its liraglutide injection in 17 emerging markets. The two parties will leverage their respective strengths to jointly expand the overseas market for the liraglutide injection.
This on-site audit was conducted strictly in accordance with the PIC/S GMP Guide, and covered the full chain of activities, including manufacturing, quality control testing, warehousing, and the quality management system.
Thanks to thorough preparation and efficient on-site coordination of the two parties, the audit proceeded smoothly. The Brazilian auditors gave strong recognition and confirmed that the product passed the on-site audit with no deficiencies identified.
Brazil is the largest country in South America by land area and by population (about 210 million people). Its overall economic size and pharmaceutical market scale rank among the world's leading markets. According to the 11th edition of the International Diabetes Federation (IDF) Global Diabetes Atlas (2024), there were about 16.62 million diabetes patients aged 20 to 79 in Brazil, with a prevalence rate of 10.7%. Among these, undiagnosed cases accounted for a high proportion, reaching 31.9%. The average annual expenditure per patient related to diabetes is 2,714.9 US dollars.
Brazil officially joined PIC/S on January 1, 2021. Its pharmaceutical GMP regulatory standards are widely recognized for their rigor and have become a benchmark for emerging pharmaceutical markets. The zero-deficiency outcome of this on-site GMP audit provides important endorsement for the liraglutide injection's entry into the Brazilian market and other markets across South America.
As more products, such as the liraglutide (a GLP-1 analog) and insulin series, pass factory inspections and receive approvals in more countries and regions, the Company will speed up its global expansion. In the future, more high-value products will enter international markets, providing safe, effective, and affordable treatments, giving patients more choices, and driving the Company's long-term growth.
