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Zydus Lifesciences Shares Gain on Tentative Nod from USFDA for Palbociclib Tablets

The drug has undergone rigorous quality testing for nitrosamines and potential genotoxic impurities.

On June 30, Zydus Lifesciences rose and gained 1% in the early trade after the company received USFDA approval for breast cancer drugs.


Zydus Lifesciences has acknowledged tentative approval from the United States Food and Drug Administration (USFDA) for Palbociclib tablets, available in 75 mg, 100 mg, and 125 mg strengths.


Palbociclib treats breast cancer, and its 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.
Palbociclib had yearly sales of $3.3 billion in the US as per IQVIA MAT in April 2023.


The group now has 373 sanctions and has so far filed over 442 ANDAs since the beginning of the filing process in FY03-04.


Last week, Zydus Animal Health and Investments Limited, a wholly owned subsidiary firm of Zydus Lifesciences, entered into a share purchase agreement with Rising Sun Holdings Private Limited (seller) and Mylab Discovery Solutions Private Limited to obtain 65,06,500 equity shares having a face value of Re 1 each at a decided deliberation of Rs 106 crores on behalf of 6.5% of the total paid-up equity share capital of Mylab from the seller.
At 9:28 am, Zydus Lifesciences was trading at Rs 582.25, up Rs 0.20, or 0.03% on the BSE.

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