Zydus Lifesciences gets USFDA approval for Palbociclib tablets

30 Jun 2023 , 10:46 AM

Zydus Lifesciences’ stock rose 1% in early trading on June 30 after the company received USFDA approval for a breast cancer drug.

Palbociclib tablets, available in 75 mg, 100 mg, and 125 mg strengths, have received preliminary approval from the United States Food and Drug Administration (USFDA).

Palbociclib is used to treat a specific type of breast cancer and works by slowing or stopping cancer cell growth.

The product will be manufactured at the group’s formulation manufacturing facility in Ahmedabad’s Special Economic Zone.

As per the IQVIA MAT report for April 2023, the sales of Palbociclib in the United States amounted to $3.3 billion on an annual basis.

Since the beginning of the filing process in FY 2003-04, the group has received 373 approvals and filed over 442 ANDAs.

Zydus Animal Health and Investments Limited, a company owned entirely by Zydus Lifesciences, recently made an agreement with Rising Sun Holdings Private Limited (the seller) and Mylab Discovery Solutions Private Limited. 

According to this agreement, Zydus Animal Health and Investments Limited will purchase 6,506,500 equity shares of Mylab, each with a face value of Rs 1. The total cost for this acquisition is agreed upon as Rs 106 crore, which represents 6.5% of Mylab’s overall paid-up equity share capital.

At around 10.44 AM, Zydus Lifesciences was trading 0.42% lower at Rs 580, against the previous close of Rs 582.45 on NSE.

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