Lunan Pharmaceutical Group’s miglitol raw material received approval from India’s DCGI

April 27, 2026  Source: drugdu 27

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Recently, Lunan Pharmaceutical Group Lunan New Era Biotechnology Co., Ltd. received a drug registration certificate for miglitol issued by the DCGI (Drug Controller General of India, the highest administrative agency in India responsible for drug regulation). This is the second approval for the new process of miglitol raw material after it was approved by the MFDS in South Korea earlier this year.

India holds a significant position in the global generic drug industry, and Lunan Pharmaceutical Group has established long-term, close, and friendly cooperative relationships with many well-known Indian pharmaceutical companies. The successful completion of this registration demonstrates our company's strong capabilities in R&D, quality control, and registration management.

Miglitol is an oral hypoglycemic agent belonging to the class of alpha-glucosidase inhibitors, primarily used to treat type 2 diabetes . It works by inhibiting alpha-glucosidase on the small intestinal mucosa, thus slowing the breakdown and absorption of carbohydrates and reducing postprandial blood glucose spikes. This product is currently marketed in several countries and regions, including Japan, South Korea, and India .

Established in 2017, the International Drug R&D Center serves as a window for Lunan Pharmaceutical Group's internationalization. Adhering to the internationalization strategy of "based in China, radiating globally," it has currently obtained 30 formulation approvals in China, the US, and Europe, 66 formulation approvals in emerging markets, 8 CEP certificates, and submitted over 40 DMF (Drug Manufacturing File) applications in Europe, the US, and Japan, and over 50 DMF applications in other emerging markets. With the development and launch of more products, the center will undoubtedly accelerate the company's pace in entering the international market, enhance Lunan Pharmaceutical's brand image and reputation both domestically and internationally, and lay the foundation for "Lunan Pharmaceutical's vision of a healthy world."

https://mp.weixin.qq.com/s/NmU3Cpyor9xAU7zPcasyKw

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