Page 6 - Dr Reddy's
Dr Reddy's faces class action lawsuit in US court
The drug maker said the case has been filed in the US District Court for the District of New Jersey
 "Dr Reddy's faces class action lawsuit in US court")
Dr Reddy's seeks recovery this fiscal year
The Hyderabad-based firm saw consolidated revenue dip nine per cent in the last fiscal year
Triggers falling in place for Dr Reddy's
As facilities get US FDA nod, pace of product launches will improve
Dr Reddy's sees no impact from pricing regulator notice
NPPA has issued a show-cause notice to dozens of Indian and foreign drugmakers
Dr Reddy's launches 2 drugs in US for reducing cholesterol
The product is a generic version of MSD International GmbH's Vytorin tablets
Brief respite for Dr Reddy's, recovery some time away
After a series of regulatory setbacks, Dr Reddy's Laboratories got some respite with its Srikakulam facility getting only two observations by USFDA after a recent inspection. The fact that the company's Duvvada facility inspections a few weeks ago had led to 13 observations, many of which are said to be serious in nature had kept the Street nervous. The stock that had fallen to of Rs 2,560, has seen some recovery and is currently trading at Rs 2,711 levels.The Srikakulam facility is among the three facilities for Dr Reddy's that had received warning letters. Majority of important filings for US launches by the company are from this plant. Thus reacting to completion of FDA audit at Srikakulam, analysts at Kotak Institutional Equities say that this is a positive outcome. However, Ithey still believe that the facility will take 5-6 months to get a complete clearance. With the inspections behind it, the attention of Street and analysts will now shift to regulatory clearance of its ...
 "Brief respite for Dr Reddy's, recovery some time away")
Dr Reddy's may leverage relationship with partners for new US launches
The company has launched only 3 new products during 2015 when compared to 14 launches in 2014
Dr Reddy's fails one more US FDA test
BS ReporterHyderabad, 9 MarchIn a continued set back to drug major Dr Reddy's Laboratories Limited's remediation efforts, its oncology formulations facility at Duvvada in Visakhapatnam of Andhra Pradesh has received Form 483 with 13 observations from the US Food and Drug Administration(US FDA) following a fresh audit that was concluded on Thursday.This is the second unit that has failed to clear the re-audit after the company had invited the drug regulator for a fresh evaluation of all the three facilities that were issued a warning letter in November 2015 over some lapses in current good manufacturing practices(CGMPs)."The US Food and Drug Administration (FDA) has issued a Form-483 with 13 observations, which we are addressing," the company said in a statement without providing any further details on nature of these observations.The company recently announced that all the commitments as part of the warning letter response have been completed. However the fresh observations, which ...
 "Dr Reddy's fails one more US FDA test")
In US, competition for Dr Reddy's intensifies
Resolution of US regulatory issues remains the biggest trigger for the stock
 "In US, competition for Dr Reddy's intensifies")
Dr Reddy's Q3 net profit down 19% at Rs 470 crore
Decline was due to fall in revenues from US, its key market in terms of generic sales and margins
South Korean firm sues Dr Reddy's in US court
Mezzion Pharma accuses Dr Reddy's of fraud by hiding significant deficiencies in CGMP regulations
 "South Korean firm sues Dr Reddy's in US court")
Dr Reddy's launches osteoporosis drug in US market
It launched Raloxifene hydrochloride tablets in 60 mg
 "Dr Reddy's launches osteoporosis drug in US market")
Dr Reddy's Foundation launches new skill development initiative
Under the new model designed to be more impactful and self-sustainable, DRF has inaugurated 110 centres across the country
 "Dr Reddy's Foundation launches new skill development initiative")
Dr Reddy's launches Nitroglycerin tablets in the US
A medicine that opens blood vessels to improve blood flow, used to treat patients complaining of chest pain among other symptoms
 "Dr Reddy's launches Nitroglycerin tablets in the US")
Dr Reddy's gets nod to export 15 drugs to EU
The order will enable the company to import these substances for a period of three years, ending June 2019
 "Dr Reddy's gets nod to export 15 drugs to EU")
Dr Reddy's delivers a bitter pill
Higher competition led to poor performance even as three plants remained under the US FDA scanner
 "Dr Reddy's delivers a bitter pill")
Dr Reddy's completes Rs 1,569.41 crore share buyback
In February this year, the company's board had approved a proposal to buyback shares
Growth challenges remain for Dr Reddy's
Acquisition of drug applications positive, but resolution of US regulatory issues holds key
 "Growth challenges remain for Dr Reddy's")
Dr Reddy's buys 8 US drugs from Teva, Allergan for $350 million
The combined sales of the branded versions of the products in the US is about $3.5 bn
US Consumer Product Safety Commission seeks action against Dr Reddy's
Panel alleges drug maker failed to report a 'non-compliance, defect, unreasonable risk' relating to blister packs as is legally required
 "US Consumer Product Safety Commission seeks action against Dr Reddy's")
