Lupin gets nod from USFDA for two abbreviated new drug applications

The pharma major on Friday announced that it received approval from United States Food and Drug Administration (USFDA) for pregabalins and iloperidone tablets.

Pregabalin capsules are used to treat epilepsy and anxiety while Iloperidone tablets are used to treat the symptoms of psychotic (mental) disorders, such as schizophrenia.

Pregabalin capsules are market a generic equivalent of Lyrica capsules by Upjohn US 2 LLC. According IQVIA, Pregabalin capsules have an estimated annual sales annual sales $263 million in the US for March 2022.The product will be manufactured at company's facility in Aurangabad, India

Iloperidone tablets are market a generic equivalent of Fanapt tablets by Vanda Pharmaceuticals. According IQVIA, iloperidone tablets had estimated annual sales of $162 million in the U.S (March 2022). Lupin said that the tablets will be manufactured at its facility in Goa, India.

Lupin is a transnational pharmaceutical company. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the U.S., India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

The company's consolidated net profit jumped 24.47% to Rs 545.52 crore on a 3.57% rise in total revenue from operations to Rs 4,160.93 crore in Q3 FY22 over Q3 FY21.

Shares of Lupin closed 0.32% lower at Rs 723.95 on Friday.

Powered by Capital Market - Live News