Cipla: USFDA approval clears path for Abraxane launch

CIPLA ANNOUNCED ON April 11 that it has received final approval from the USFDA for its Abraxane (Paclitaxel protein-bound particles for injectable suspension [albumin bound], 100 mg/vial, single-dose vial) ANDA.

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The approval pertains to Cipla's Goa site, which was cleared by the USFDA in October 2024. While the approval is not entirely unexpected, there were concerns about potential delays due to the possibility of a pre-approval inspection. However, we think the approval thus presents visibility on launch. Cipla expects to launch the product in the first half of FY26, earlier than its initial guidance of a second-half FY26 launch. However, as production ramp-up and supply initiation may take time, we anticipate the launch to occur towards the end of 1HFY26.