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Amneal and Shilpa Announce US FDA Approval for BORUZU, the First Ready-to-Use Version of Bortezomib for Subcutaneous Administration Page 1

Amneal and Shilpa Announce US FDA Approval for BORUZU, the First Ready-to-Use Version of Bortezomib for Subcutaneous Administration Page 1

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) and Shilpa Medicare Limited (“Shilpa”) announced the U.S. Food and Drug Administration (FDA) approval of BORUZU, a new presentation of bortezomib for ready-to-use subcutaneous or intravenous (IV) administration. This new ready-to-use oncology product reduces the compounding steps typically required for administration.

BORUZU (bortezomib injection), a proteasome inhibitor, is used to treat multiple myeloma and mantle cell lymphoma. This product refers to the branded product Velcade, a freeze-dried powder that needs to be reconstituted before use. Shilpa developed the molecule and Amneal will manufacture and commercialize the product. BORUZU is expected to be launched in the second quarter of 2025 with a unique J-code.