Cipla Gets USFDA Nod for Cancer Drug Paclitaxel

15 Apr 2025 , 11:38 AM

Cipla Ltd. has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Paclitaxel, a generic version of Bristol Myers Squibb’s Abraxane.

Paclitaxel is an AB-rated therapeutic alternative of Abraxane, one of the most important oncological medicines in treating metastatic breast cancer, advanced or metastatic non-small cell lung cancer (NSCLC) and metastatic pancreatic cancer.

The firm stated that it is now set to introduce the product in the United States in H1FY26 (the first half of the financial year 2025–26), earlier than anticipated.

Cipla’s Q3 FY24 performance was ahead of expectations on all financial parameters boosting investor confidence in its growth trajectory. For the quarter, net profit soared 49% on-year to ₹1,570 crore, on the back of higher revenue and better operating efficiency. For the December quarter, revenue was ₹7,073 crore, a 7% increase over the same quarter of the previous financial year.

Earnings before interest, tax, depreciation and amortisation (EBITDA) stood at ₹1,989 crore, a year-on-year increase of 14%. The EBITDA margin for the quarter increased 200 basis points from the prior year period, coming in at 28% vs. 26%, reflecting better cost management. Cipla’s average EBITDA margin for the first nine months of this financial year was 26.9%, which was above its full-year margin guidance of 24.5% to 25.5%.