Pharmaceutical manufacturer Velpharm Group has received a registration certificate for a alpha-lipoic acid concentrate to treat diabetic polyneuropathy (DPN), the company told GxP News.
Diabetic polyneuropathy, a very common complication of diabetes, is nerve damage from long-term high blood sugar. In severe cases, it can lead to foot ulcers, amputation due to the “diabetic foot syndrome,” and problems with the heart, digestion, and other body systems.
Alpha-lipoic acid, an endogenous antioxidant with direct and indirect mechanisms of action, is included in the clinical guidelines for treating diabetic polyneuropathy from both the EU and the International Diabetes Federation. Although the drug is not included in Russian clinical guidelines, the company stated it is widely used in practice, often in combination with B vitamins. Alpha-lipoic acid is known to reduce pain, improve nerve sensitivity, and help regulate carbohydrate and fat metabolism.
“The rising prevalence of diabetes is driving growing demand for pharmaceuticals used to treat both the disease and its complications. In Russia, sales of alpha-lipoic acid in the form of a concentrate for infusion solution reached 4.3 million packages in 2024. In the first half of 2025 alone, sales surpassed 2 million packages. The sustained market demand for this endogenous antioxidant indicates that increasing the number of manufacturers of this VED-listed drug will enhance its accessibility for patients,” the report states.
Velpharm Group is a Russian pharmaceutical holding company that manufactures a wide range of medicines, from active pharmaceutical ingredients to finished dosage forms, in a full-cycle process. The Group operates four production facilities: two dedicated to manufacturing finished pharmaceuticals and two focused on producing active pharmaceutical ingredients (APIs). Its product portfolio comprises more than 300 medicines, with 75% included in the Vital and Essential Drugs list.
