--- title: "Gan & Lee Pharmaceuticals' commercialization layout in the Brazilian market has made further progress, achieving dual compliance from raw materials to formulations" type: "News" locale: "en" url: "https://longbridge.com/en/news/287648701.md" description: "Gan & Lee recently obtained the Good Manufacturing Practice certification from the Brazilian Health Regulatory Agency, covering two core formulation products: Aspart Insulin and Lispro Insulin. This marks the full compliance of its active pharmaceutical ingredients and formulations in the Brazilian market. This will lay the foundation for Gan & Lee's own brand of insulin to enter the Brazilian market, enhancing the medication options and accessibility for local diabetes patients" datetime: "2026-05-26T14:09:17.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/287648701.md) - [en](https://longbridge.com/en/news/287648701.md) - [zh-HK](https://longbridge.com/zh-HK/news/287648701.md) generator: "portal-rs" --- # Gan & Lee Pharmaceuticals' commercialization layout in the Brazilian market has made further progress, achieving dual compliance from raw materials to formulations Recently, Gan & Lee Pharmaceutical Co., Ltd. (hereinafter referred to as "Gan & Lee Pharmaceutical") announced that the company has successfully obtained the Good Manufacturing Practice (GMP) certification issued by the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária, ANVISA). This certification covers two core formulation products: aspart insulin and lispro insulin. With this, Gan & Lee Pharmaceutical has achieved full compliance of the insulin raw material and formulation production system in the Brazilian market, laying a crucial foundation for its own brand insulin to enter Brazil and deepen its presence in the Latin American market. From the perspective of product value, aspart insulin and lispro insulin are both commonly used rapid-acting insulin analogs in clinical practice. Among them, aspart insulin injection takes effect quickly within 10-20 minutes after subcutaneous injection, with peak action occurring 1-3 hours post-injection and a duration of action lasting 3-5 hours, effectively controlling postprandial blood sugar; lispro insulin also possesses rapid onset and flexible administration characteristics, meeting the individualized treatment needs of different patients. The simultaneous approval of both products through Brazil's GMP certification will further enrich the local diabetes medication options and enhance the accessibility of high-quality biopharmaceuticals. **Tapping into the Brazilian Market and Competing with International Giants** Brazil has a large number of diabetes patients. According to data from the International Diabetes Federation (IDF), there are 16.62 million diabetes patients aged 20-79 in Brazil, with related medical expenditures ranking third globally. Currently, insulin formulations in Brazil are mainly supplied by companies such as Eli Lilly, Novo Nordisk, and Sanofi. In the face of this market dominated by international giants, domestic insulin is actively striving for market share through technological breakthroughs and compliance advantages. As early as 2014, Gan & Lee Pharmaceutical began its strategic layout in Brazil and has successfully completed the registration and market launch of glargine insulin in Brazil. Through continuous penetration and in-depth layout in the Brazilian market, Gan & Lee Pharmaceutical is actively supporting the Brazilian public health system's market demand for insulin, enhancing the accessibility of insulin for diabetes patients in Brazil, and promoting the upgrade of insulin treatment structures. **Dual Certification for Raw Materials and Formulations Achieving a Full Chain Qualification Loop** With the implementation of this formulation GMP certification, Gan & Lee Pharmaceutical has achieved full coverage of the production system for glargine insulin, aspart insulin, and lispro insulin raw materials and formulations under Brazil's ANVISA GMP certification, successfully constructing a full chain qualification loop from raw materials to formulations. This represents a further deepening and continuation of Gan & Lee Pharmaceutical's earlier layout in the Brazilian market, providing a compliant foundation for subsequent product approvals. The Brazilian Health Regulatory Agency (ANVISA), as a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), aligns its GMP certification standards with international mainstream regulatory systems. This certification not only represents another important international regulatory recognition for Gan & Lee Pharmaceutical following its successful approval from the European Medicines Agency (EMA) GMP but also validates the high compatibility of its production process platform—meaning that the same quality system can support differentiated production and regulatory submissions for different products It is worth mentioning that the two products mentioned above have also made significant progress in the international market recently. In February 2026, Gan & Lee's Liraglutide Injection and Aspart Insulin Injection received positive opinions from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), marking a key breakthrough for Gan & Lee in one of the highest standard drug review systems globally in Europe, further confirming the company's steady improvement in research and development capabilities, quality management systems, and international registration capabilities. At this stage, Gan & Lee has the industrialization production technology for recombinant insulin analogs, and while deeply cultivating the core metabolic disease field, it is also systematically laying out research and development pipelines in areas such as autoimmune diseases. The successful GMP certification of the two products in Brazil provides a mature and feasible practical solution for the company's overseas scaled expansion. In the future, Gan & Lee will accelerate the market layout and product establishment of its own brand insulin in Brazil, benefiting local diabetes patients with high-quality and highly accessible products ### Related Stocks - [603087.CN](https://longbridge.com/en/quote/603087.CN.md) - [LLY.US](https://longbridge.com/en/quote/LLY.US.md) - [NVO.US](https://longbridge.com/en/quote/NVO.US.md) - [SNY.US](https://longbridge.com/en/quote/SNY.US.md) - [SNYNF.US](https://longbridge.com/en/quote/SNYNF.US.md) ## Related News & Research - [China's Volume‑Based Procurement System Drives Domestic Insulin Supplier to Go Global](https://longbridge.com/en/news/295907379.md) - [09:18 ETThe Bybit Card Advantage: Exclusive Pre-Sale Access to Tomorrowland Brasil 2027 Tickets](https://longbridge.com/en/news/296623403.md) - [HENGRUI PHARMA 1H26 Net Profit Rises 0.3% YoY to RMB4.465 Billion; Shares Now Down Over 7%](https://longbridge.com/en/news/296422700.md) - [CANSINOBIO Tetanus Vaccine New Drug Application Approved](https://longbridge.com/en/news/296498620.md) - [Norway PM Støre to open Thor Medical AlphaOne isotope facility Sept. 9](https://longbridge.com/en/news/296304032.md) --- > **Disclaimer: This article is for reference only and does not constitute any investment advice.**