Page 6 - Dr Reddy's
USFDA's warning letter continues to haunt Dr Reddy's even after 3 years
The latest Form 483 with 8 observations came as a clear setback for the company, which was hoping to complete the remediation without giving a scope for any more observations
 "USFDA's warning letter continues to haunt Dr Reddy's even after 3 years")
Dr Reddy's facility fails to clear the inspections by USFDA yet again
The fresh round of concerns raised by the USFDA inspectors over the Oncology formulations facility comes as a big setback to the company
 "Dr Reddy's facility fails to clear the inspections by USFDA yet again")
Dr Reddy's gets USFDA nod to market aspirin, anti-coagulant drug in US
Aspirin is used to treat pain, fever or inflammation while dipyridamole is used as an anti-coagulant
Dr Reddy's Laboratories terminates Armis Biopharma's investigation license
DFA-02 has been studied in several phase 1 and 2 clinical studies
 "Dr Reddy's Laboratories terminates Armis Biopharma's investigation license")
Dr Reddy's gets exclusive right to distribute UCB's epilepsy drug in India
Briviact is approved as an adjunctive therapy for the treatment of partial-onset seizures in epilepsy patients who are 16 years of age and older
US price erosion weighs on Dr Reddy's; Q4 net down 3% to Rs 3 billion
There are not many growth triggers for the company, say analysts
 "US price erosion weighs on Dr Reddy's; Q4 net down 3% to Rs 3 billion")
Dr Reddy's files new drug application for migraine spray with USFDA
Upon approval, the product will be commercialised by Promius Pharma
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 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 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
