Zydus Lifesciences Ltd. shares recorded a new 52-week high of Rs 594.6 per on Monday after the company’s Ahmedabad unit received an ‘Establishment Inspection Report’ (EIR) from the United States Food and Drug Administration (USFDA).
Zydus Lifesciences informed the stock exchanges that the US drug regulator conducted an inspection at the Pharmez unit in Ahmedabad between March 20-24, 2023. The inspection has been closed with a ‘voluntary action indicated’ (VAI) recommendation in the EIR.
“The inspection has been classified as Voluntary Action Indicated (VAI). The EIR report indicates that the inspection is closed,” Zydus Lifesciences said in its disclosure to the stock exchanges on Monday.
Last week, Zydus Lifesciences received tentative approval from the USFDA for palbociclib tablets in the dosages 75 mg, 100 mg, and 125 mg.
These tablets are used in the treatment of a certain type of breast cancer as it stops or slows down the growth of cancer cells.
The drug maker reported a 25.36 percent decline in its consolidated net profit at Rs 296.6 crore in the last quarter of the financial year ended March 31, 2023, due to an impairment of goodwill of a wholly-owned subsidiary.
The company’s consolidated total revenue from operations, however, increased 31.66 percent to Rs 5,010.6 crore in the March quarter as against Rs 3,805.6 crore in the same period last year.
Shares of Zydus Life have risen nearly 38 percent on a year-to-date basis.
