Page 7 - Dr Reddy's
Dr Reddy's appoints Erez Israeli as COO and head of global generics biz
Israeli will join Dr Reddy's on April 2, 2018. He will report to its co-chairman and CEO G V Prasad
 "Dr Reddy's appoints Erez Israeli as COO and head of global generics biz")
Dr Reddy's launches anti-nausea injection for cancer patients in US
Drug is a therapeutic equivalent of USFDA-approved Aloxi injection, whose sales in 12 months to Jan 2018 were $446 mn
 "Dr Reddy's launches anti-nausea injection for cancer patients in US")
Dr Reddy's is awaiting 102 approvals from US Food and Drug Administration
The US drug regulator raised the issue of significant deviations from the current good manufacturing practice (cGMP) in three of DRRD's plants in a letter issued in November 2015
 "Dr Reddy's is awaiting 102 approvals from US Food and Drug Administration")
Dr Reddy's Labs shares extend losses, down 3%
The stock was the biggest drag on both the key indices Sensex and Nifty during the day
Dr Reddy's Lab settles blister package case in US for $5 mn
US Consumer Product Safety Commission(CPSC) has requested the US Department of Justice to impose civil penalty on Dr Reddy's
Dr Reddy's launches anti-depressant, muscle relaxant tablets in US
BS ReporterHyderabad, 6 September: Dr Reddy's Laboratories Limited announced today that it has launched anti-depressant, Bupropion Hydrocholoride Extended Release Tablets, 150 mg and 300 mg, as well as muscle relaxant drug Metaxalone in the US market. The anti-depressant drug is a generic equivalent version of Wellbutrin XL, a trademark of GlxoSmithKline LLC. The brand and generic sales of the drug was approximately $ 754 million for the recent twelve months ending July, 2017, according to IMS Health. It may be recalled that Indian generic companies Cipla and Lupin had launched Wellbutrin's generic version of 150 mg and 300 mg dose tablets in April, 2016 and June 2017 respectively.However, the generic version of Welbutrin SR(100 mg, 150 mg and 200 mg) is being sold by Dr Reddy's since September, 2016.Metaxalone, which is used for treatment of skeletal muscle conditions such as pain and injury, is a generic equivalent version of Skelaxin brand of King Pharmaceuticals Research and ...
Dr Reddy's settles patent row with Vivus; stock gains over 7%
The stock opened at Rs 2,130 and had hit a high and low of Rs 2,169 and Rs 2,121 respectively
 "Dr Reddy's settles patent row with Vivus; stock gains over 7%")
Dr Reddy's needs to take lead in corporate governance: Analysts
BS ReporterHyderabad, 29 August: The class action suit filed by a US law firm against New York Stock Exchange-listed Dr Reddy's Laboratories Limited has only underlined the need for strengthening corporate governance practices by the management in the light of a series of regulatory set backs faced by the company in the recent past, according to some analysts.They believe that the issues that led to the recent changes at the helm of Indian IT giant Infosys will keep returning to the big companies in one way or the other and it was high time for Dr Reddy's leadership also to stop thinking about taking only incremental steps in that direction."Being a leader people expect Dr Reddy's to set a bench mark in corporate governance in running the company affairs or in maintaining transparency as Infosys founders did in the past. The issues raised in the class action law suit were not entirely new. Even in India also investors had been demanding for better transparency from the company," ...
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 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 ...
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 ...
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")
