Recently, Shuerte® Thioctic Acid Tablets (specification: 0.6g) of Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group , were approved for marketing by the National Medical Products Administration and are regarded as having passed the consistency evaluation of generic drug quality and efficacy. Approval number: National Drug Approval Number H20266515.
This product is indicated for sensory abnormalities caused by diabetic peripheral neuropathy. Lipoic acid is a B vitamin and a coenzyme for pyruvate dehydrogenase and α-ketoglutarate dehydrogenase systems. In vitro studies show that lipoic acid can reduce lipid oxidation in nerve tissue and inhibit protein glycosylation and aldose reductase. In vivo, lipoic acid has antioxidant activity and participates in the recycling of antioxidants such as glutathione and coenzyme Q10. This product is rapidly absorbed after oral administration. Due to a significant first-pass effect, the absolute bioavailability (compared to intravenous injection) is approximately 20%, and the plasma half-life is approximately 25 minutes. Compared to oral solutions, the relative bioavailability of the oral solid dosage form is 60%.
Previously, our company's thioctic acid injection was approved for marketing by the National Medical Products Administration in 2021. This approval of the oral tablets completes the dosage form supplementation, providing clinicians and patients with more flexible medication options to suit diverse treatment scenarios.

Source: https://bydrug.pharmcube.com/news/detail/2c3c1bb727f11d4015c7edc246d32b3d