Zydus receives tentative approval from the USFDA for Palbociclib Tablets, 75 mg, 100 mg, and 125 mg

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as "Zydus") has received tentative approval from the United States Food and Drug Administration (USFDA) for Palbociclib Tablets, 75 mg, 100 mg, and 125 mg (USRLD: Ibrance Tablets, 75 mg, 100 mg, and 125 mg).

Palbociclib is used to treat a certain type of breast cancer. It works by slowing or stopping the growth of cancer cells. The product will be manufactured at the group's formulation manufacturing facility in SEZ, Ahmedabad (India).

Palbociclib Tablets, 75 mg, 100 mg, and 125 mg had annual sales of USD 3.3 bn in the United States (IQVIA MAT April 2023).

The group now has 373 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 570.85 as compared to the previous close of Rs. 561.85. The total number of shares traded during the day was 98537 in over 5498 trades.

The stock hit an intraday high of Rs. 574.40 and intraday low of 552.75. The net turnover during the day was Rs. 56170364.00.

(*as of 31st March 2023)

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 USFDA TentativeApproval PalbociclibTablets