The quality of domestic generic drugs is worrying and needs technological innovation

[market analysis of chinapharma.com] the quality of China's generic drugs is controversial in the world, and due to the different quality standards, it is difficult for domestic generic drugs to cross over But now that has changed On March 18, Qingdao Baiyang pharmaceutical announced that Nida, its osmotic pump metformin sustained-release tablets, was officially delivered to the United States and will be officially sold in the United States This also means that Chinese pharmaceutical companies have made breakthroughs in the quality and innovation of generic drugs It is understood that metformin is the main treatment for type 2 diabetes In the U.S market, sustained-release and controlled-release formulations are more popular because of their advantages of good efficacy and high safety, accounting for 94% of the market share However, there are only three metformin osmotic pump preparations in the United States, accounting for 30% of the market, and the original products are expensive By contrast, Nida's price is more advantageous It is reported that Nida will be listed in China within this year, and the price is only 1% of the original drug research enterprises in the United States It is reported that the osmotic pump controlled release technology used by Nida makes the drug release in the body at a constant speed, and the blood concentration is more stable It reduces gastrointestinal tract stimulation and side effects, as well as the number of times of taking medicine for diabetic patients At the same time, Nida is consistent with the original drug in active ingredients, administration route, dosage form, use conditions and bioequivalence Fu Gang, chairman of Baiyang Pharmaceutical Group, said that with the delivery of Nida products to the United States, Chinese drugs will also stand on the international stage, and will be sent to Europe, Japan and South Korea and other countries in the future to accept market inspection with practical and reliable quality This also means that in the future, Chinese drugs will have more confidence in the international market and participate in international competition Looking back at the development of China's generic industry, although China is a big country of generic drugs, domestic generic drugs have been staying in the "generic standard stage" for a long time, only achieving the replication of chemical structure, the low level of industrialization of preparations, the poor quality of pharmaceutical excipients, and many impurities, leading to the quality of domestic generic drugs, let alone cross According to the industry, the key to solve the quality problem of generic drugs is technological innovation Only by mastering the core technology of developing generic drugs can the quality level of products be continuously improved to international standards But it is easy to copy the structure, and the way of independent innovation is not simple As Fu Gang, chairman of Baiyang Pharmaceutical Group, said, "there is a certain technical barrier to the oral preparation of osmotic pump controlled release technology, which has higher requirements for preparation process, preparation equipment, quality control and operators, especially in large-scale industrial production, it is difficult to ensure the consistency within and between batches, and the production cost is also large." Limited by the factors of preparation technology, preparation equipment, personnel and so on, the pharmaceutical enterprises that can master this preparation technology in China are more difficult to break through in the U.S market Domestic generic pharmaceutical enterprises must pay more attention to innovation, constantly explore and strive to make greater progress At present, with the rapid development of measures such as volume purchasing, the pharmaceutical market structure in China is facing reconstruction, and the concentration of generic pharmaceutical industry is also constantly improving, which forces pharmaceutical enterprises to actively develop innovative and high-quality generic pharmaceutical products In addition, the industry said that with national and local support for generic innovation, the domestic generic industry will generate more new drugs and new technologies in the wave of new and old energy conversion At present, Baiyang pharmaceutical's international research products of oral solid preparations have been selected into 5 In addition to Nida, it also includes duloxetine hydrochloride enteric coated capsules, glipizide controlled-release tablets, nifedipine controlled-release tablets and carbamazepine controlled-release tablets It is reported that in the next step, Baiyang pharmaceutical will step up the domestic approval application, and is expected to be listed in China within this year, which will benefit more domestic diabetes patients.