Shilpa Medicare rallied 3.31% to Rs 756.85 after the company announced that it has received the U.S. Food and Drug Administration (USFDA) approval for its second new drug application (NDA), Bortezomib injection.
The said product is the first liquid injection for Bortezomib, approved for both subcutaneous and intravenous administration by the USFDA. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL).
The injection is ready to use for subcutaneous administration, offering significant advantages to the health care providers. The injection has to be diluted for intravenous use. The reference product Velcade is a lyophilized injection which requires reconstitution prior to administration.
Bortezomib Injection, a proteasome inhibitor, contains bortezomib which is an antineoplastic agent. This NDA provides for the use of Bortezomib injection for the treatment of adult patients with multiple myeloma and for the treatment of adult patients with mantle cell lymphoma.
Vishnukant Bhutada, managing director of Shilpa Medicare, said This second NDA approval in the US market from our novel injectable portfolio is a testament of our capabilities and commitment to introduce patient centric solutions that enhance compliance and ease of administration. I am very pleased to see that our relentless endeavour and self-belief of investing in various value added products across different segments have started paying off with monetization opportunities being created in each of the segments, laying a stronger foundation for the future.
Vishnukant Bhutada, managing director, Shilpa Medicare said, This development exemplifies Shilpas constant endeavor to work towards introducing novel first of its kind pharmaceutical products that help improve the healthcare requirements of a large patient pool.
Raichur-based Shilpa Medicare is a vertically integrated, manufacturer and distributor of quality drugs to global markets; specializing in the oncology therapeutic segment and introducing novel drugs focusing on patient convenience and compliance.
The company reported consolidated net profit of Rs 14.06 crore in Q1 FY25, steeply higher than Rs 1.18 crore posted in Q1 FY24. Revenue from operations grew by 12.4% year on year to Rs 292.51 crore in the quarter ended 30 June 2024.
The counter hit an all-time high of Rs 765.00 on the BSE.
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