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A Voluntary Action Indicated (VAI) status means that objectionable conditions or practices were found at the facility, but the agency (USFDA) is not prepared to take or recommend any administrative or regulatory action. It is lower than the Official Action Indicated (OAI) status, which means regulatory and / or administrative actions are recommended.
The US drug regulator had conducted a routine current Good Manufacturing Practices (cGMP) inspection at the said facility between November 7 to November 13, 2024.
The drugmaker recently declared its December quarter results, which were a beat across parameters.
Revenue for the quarter stood at ₹7,073 crore, which is a 7% growth from last year. Net profit for the period also increased by 49% from the year-ago period to ₹1,570 crore.
Cipla’s Earnings Before Interest, Tax, Depreciation and Amortisation (EBITDA) grew by 14% year-on-year to ₹1,989 crore.
EBITDA margin for the period expanded by 200 basis points to 28% from 26% last year. For the first nine months of the financial year, Cipla’s EBITDA margin 26.9%, which is higher than the management guidance of 24.5% to 25.5% for the full year.
Sales from the US market, where Cipla derives its majority revenue from declined by 2% from last year to $226 million. However, the figure was better than the CNBC-TV18 poll of $218 million.
Shares of Cipla Ltd. ended 0.10% lower on Friday at ₹1,470.
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