An amount of Rs 17 crore is recognised as a possible refund liability (as a reduction from revenue) arising out of the company's decision to recall the said product
The drug major has reported a 26% increase in revenues at Rs 4,801 crore for Q2
Better top-lines numbers come in despite a flattish growth in the firm's US business.
Ranitidine sales account for 2 per cent of Strides sales and 6 per cent of its profit after tax
Drug major Dr Reddy's on Saturday said it has received four observations from the US health regulator USFDA for its facility at Srikakulam in Andhra Pradesh. The audit of the company's API Srikakulam Plant (SEZ) by the United States Food and Drug Administration (USFDA) was completed on Friday, the Hyderabad-based pharma major said in a regulatory filing. Dr Reddy's further said that it would address the four concerns within the stipulated timeline. "The audit of our API Srikakulam Plant (SEZ), Andhra Pradesh, by the USFDA, has been completed on October 25, 2019. We have been issued a Form 483 with four observations," said Dr Reddy's. It further said: "We will address them comprehensively within the stipulated timeline." As per the US health regulator, "an FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and ...
First Indian firm to get contract for supplying generic schizophrenia drug to public hospitals there
First Indian firm to get contract for supplying generic schizophrenia drug to public hospitals there
The Hyderabad-based company is an outlier among large pharmaceutical producers, having seen a jump in its stock price over the previous year
Dr Reddy's, Lupin, Sun Pharma and Cadila Healthcare outperformed the local industry growth in recent months, a trend expected to continue
A CRL is issued when the FDA decides not to approve new or generic drug application for marketing in its present form
Earnings were driven by one-off gains
A combination of factors, including an 8% growth in global generics business and the other operating income drove the growth in net profit of Dr Reddy's during the first quarter ended June, 2019
Allegra-D 12 HR is a trademark of Aventisub II Inc
Divestment of derma assets, lower operating costs helped firm post higher profit growth during the quarter
The pharma major is on a restructuring drive
Sources said the company got approval earlier this month for generic Clopidogrel, which is used primarily to prevent blood clotting and acts against cardiovascular problems
Shares of Dr Reddy's Laboratories were trading at Rs 2,640 per scrip on BSE, up 2.11 per cent from their previous close
Such recalls are for dangerous or defective products that predictably can cause serious health problems
This is the second plant to come out of the warning letter after multiple inspections conducted by the US drug regulator
The site was again audited in October 2018, Dr Reddy's said.