Shilpa Medicare Ltd announces USFDA Approval for Bortezomib Injection NDA 212782

Shilpa Medicare Ltd announces the approval of its second NDA [505(b)(2)], injectable product - Bortezomib Injection, by USFDA.

Bortezomib Injection is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL).

This is the first "liquid" injection for Bortezomib, approved for both subcutaneous and intravenous administration by the USFDA. 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.

"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", said Mr. Vishnukant Bhutada, Managing Director Shilpa Medicare Limited.

Shilpa's Bortezomib Injection shall be marketed by our business partner, Amneal Pharmaceutical LLC USA. The current market for the lyophilised Bortezomib in the US is about USD 95 million (MAT Q4 2023).

Shares of Shilpa Medicare Limited was last trading in BSE at Rs. 732.60 as compared to the previous close of Rs. 697.25. The total number of shares traded during the day was 66051 in over 11331 trades.

The stock hit an intraday high of Rs. 778.20 and intraday low of 697.25. The net turnover during the day was Rs. 49389784.00.

Source : Equity Bulls

Keywords

ShilpaMedicare INE790G01031 Approval USFDA BortezomibInjection Injectable