Shilpa Medicare secures USFDA’s approval for Bortezomib Injection, shares rally 4%

This is the first liquid injection for Bortezomib, approved by the USFDA for both subcutaneous and intravenous administration. The Injection is ‘ready to use’ for subcutaneous administration, offering significant advantages to healthcare providers. It has to be diluted for intravenous use. The reference product, Velcade, is a lyophilized injection that requires reconstitution prior to administration.

Bortezomib Injection, a proteasome inhibitor, contains bortezomib, an antineoplastic agent. This NDA provides for the use of Bortezomib injection to treat adult patients with multiple myeloma and mantle cell lymphoma.

Shilpa Medicare produces and exports consistently high-quality active pharmaceutical ingredients, fine chemicals, intermediates, herbal products, and speciality chemical products using sophisticated technology and meticulously following international specifications.

Following the announcement, shares of Shilpa Medicare were trading 4% higher at ₹761 apiece on the NSE. The shares of the company have rallied nearly 10% in the last two trading sessions after the company announced the successful completion of Phase 3 studies of SMLUND07- Nor Ursodeoxycholic Acid (NorUDCA) tablets on 26 Aug 2024.