Lupin Limited’s shares witnessed a 1.37 per cent surge after the company received approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Minzoya. The approved drug is a generic equivalent of Balcoltra, with the generic product being manufactured at Lupin’s facility in India. The drug is intended for use by females of reproductive potential to prevent pregnancy and is expected to provide patients with affordable healthcare options. The approval is a significant development for Lupin, strengthening its position in the generic pharmaceutical market.
The approval from the USFDA has allowed Lupin Limited to market its generic version of Balcoltra, a drug manufactured by Avion Pharmaceuticals LLC. The generic drug, Minzoya, will be produced at Lupin’s Pithampur facility in India. The Reference Listed Drug (RLD) Balcoltra had an estimated annual sales of ₹42 million in the U.S. as of IQVIA MAT December 2023. Lupin Limited believes that this approval will enhance its standing in the generic pharmaceutical market and enable it to offer more affordable treatment options to patients in need.
As a result of the approval, Lupin Limited’s shares surged by 1.37 per cent to ₹1,627.10 at 2.43 p.m. on the BSE. The company is optimistic about the impact of the approval on its market position and its ability to offer cost-effective healthcare solutions to patients in the United States.
The approval of Minzoya by the USFDA marks a significant milestone for Lupin Limited, as the company continues to make strides in the generic pharmaceutical market and expand its global presence in the healthcare industry.
Published on February 16, 2024.
