The US drug regulator inspected the plant from January 13 to February 12,2020 and issued a letter to the company to this effect while classifying the inspection as 'Official Action Indicated'
That apart, the company informed the exchanges that the US FDA has classified the inspection of the company's oral solids formulation manufacturing facility at New Jersey as Official Action Indicated
Revenues from operations for the quarter under review registered 16.4% growth at Rs 6158.43 crore as compared to Rs 5324.47 crore in the year ago period
Tata Motors' stock could be active in today's session after the company announced that it has resumed operations across all its manufacturing plants in the country
Within BSE-500, 79% stocks gave positive returns in two months of lockdown
Some see this as an opportunity for Indian firms like Alembic, Aurobindo who make both the bulk drug and the formulation
The stock hit a 52-week low of Rs 281 on March 23, 2020
The latest classification, VAI, suggests that though certain objectionable conditions were found during the review, they did not warrant any further regulatory action
The facility remains important as it contributes more than 10 per cent to Aurobindo's overall sales and about 20 per cent of the US sales
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Aurobindo was scheduled to acquire the portfolio with an upfront purchase price of $900 million in cash
The stock is trading higher for the fourth straight day and has rallied 38 per cent during the period.
Currently, Unit 4 has 15 abbreviated new drug applications (ANDA) approvals pending over the next one year.
On February 18, the US FDA issued the EIR with voluntary action indicated for Aurobindo Pharma's Unit IV injectable formulations unit
Analysts remain positive on Aurobindo's future prospects including the US despite the higher base
The Company has received the Establishment Inspection Report (EIR) with Voluntary Action Initiated (VAl) status from the US Food & Drug Administration (USFDA) for Unit IV.
The stock of the drug company was trading higher for the fifth straight day, up 14 per cent, against a 4 per cent rise in the S&P BSE Sensex during the period.
According to a filing with the bourses, revenues from operations during the quarter under review was up by nearly 12 per cent to Rs 5,895 crore. It was Rs 5,269.7 crore in Q3 FY19.
The formulations revenues for the quarter posted a growth of 17.4 per cent year-on-year at Rs 5,104 cr