Cipla Limited receives USFDA final approval for ANDA Protein-bound Paclitaxel

Cipla Limited has received final approval from the United States Food and Drug Administration ('USFDA') for the Abbreviated New Drug Application ('ANDA') submitted for Paclitaxel Protein-bound Particles for Injectable Suspension (albumin-bound), 100 mg/vial, Single-Dose Vial ('Protein-bound Paclitaxel') on 10th April, 2025.

Cipla's Protein-bound Paclitaxel is an AB-rated generic therapeutic equivalent version of Bristol Myers Squibb's Abraxane® for Injectable Suspension 100 mg/vial. Protein-bound Paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer ('NSCLC') and metastatic adenocarcinoma of the pancreas. The product is expected to be launched in H1 FY 2025-26 in the United States of America.

Shares of Cipla Limited was last trading in BSE at Rs. 1416.30 as compared to the previous close of Rs. 1433.45. The total number of shares traded during the day was 53370 in over 3817 trades.

The stock hit an intraday high of Rs. 1422.15 and intraday low of 1395.50. The net turnover during the day was Rs. 75504674.00.

Source : Equity Bulls

Keywords

Cipla INE059A01026 USFDA FinalApproval ANDA ProteinboundPaclitaxel