STOCKWATCH

SHILPA MEDICARE LTD. Receives USFDA Approval for Bortezomib Injection NDA 212782

Shilpa Medicare Ltd. has announced the approval of its second NDA [505(b)(2)], injectable product - Bortezomib Injection, by the USFDA. The injection is approved for subcutaneous or intravenous use and 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 'ready to use' injection offers significant advantages to health care providers. The current market for the lyophilised Bortezomib in the US is about USD 95 million (MAT Q4 2023).

• SHILPA MEDICARE LTD. receives USFDA approval for Bortezomib Injection NDA 212782
• Bortezomib Injection approved for subcutaneous or intravenous use
• First 'liquid' injection for Bortezomib approved for both subcutaneous and intravenous administration by the USFDA
• The injection is 'ready to use' for subcutaneous administration
• Current market for the lyophilised Bortezomib in the US is about USD 95 million (MAT Q4 2023)