Drug firm Zydus Lifesciences Ltd on Wednesday, June 28, said it has received a tentative approval from the United States Food and Drug Administration (USFDA) for palbociclib 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, the company said in an exchange filing
As of March 31, 2023, palbociclib tablets, 75 mg, 100 mg, and 125 mg had annual sales of $3.3 billion in the United States (IQVIA MAT April 2023), it said.
The group now has 373 approvals and has so far filed over 442 abbreviated new drug applications (ANDAs) as of March 31, 2023, since the commencement of the filing process in FY 2003-04.
The company reported a 25.36 percent decline in consolidated net profit at Rs 296.6 crore in the fourth quarter ended March 31, 2023, impacted by impairment of goodwill of a wholly-owned subsidiary.
Consolidated total revenue from operations stood at Rs 5,010.6 crore, as against Rs 3,805.6 crore in the corresponding period a year ago. Total expenses were higher at Rs 3,961.3 crore compared to Rs 3,311.8 crore in the year-ago quarter.
During the quarter, Zydus said it incurred an exceptional item of Rs 594.1 crore as impairment of goodwill by Sentynl Therapeutics Inc, a wholly-owned subsidiary of the group. Moreover, it also incurred a Rs 7.2-crore loss in connection with the cessation of the operations of one of the manufacturing facilities of Zydus Wellness Products.
For the fiscal ended March 31, 2023, the company's consolidated net profit stood at Rs 1,960.3 crore against Rs 4,487.3 crore in the previous fiscal. In FY23 consolidated total revenue from operations stood at Rs 17,237.4 crore, compared to Rs 15,109.9 crore in FY22.
Shares of Zydus Lifesciences Ltd ended at Rs 582.05, up by Rs 20.20, or 3.60 percent on the BSE.
(Edited by : Shoma Bhattacharjee)
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