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Key Developments: Dr.Reddy's Laboratories Ltd (REDYf.NS)

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Latest Key Developments (Source: Significant Developments)

Dr. Reddy's Labs acquires six OTC brands from Ducere Pharma
Wednesday, 25 May 2016 05:27am EDT 

Dr.Reddy's Laboratories Ltd : Dr. Reddy's enters the branded consumer health arena through the acquisition of six OTC brands . Co acquired six OTC brands from Ducere Pharma .  Full Article

Dr.Reddy's expects more launches in North America in fiscal 2017
Thursday, 12 May 2016 07:31am EDT 

Dr.Reddy's Laboratories Ltd : COO mukherjee says spent 136 crore rupees in Q4 on remediation of plants under November warning letter . COO says expect more product launches in North America in fiscal 2017 versus a year earlier . Labs COO says to send final update to FDA on warning letter by may with nearly 90 percent of issues resolved . Further company coverage [REDY.NS] ((Bengaluru Newsroom; +91 80 6749 1130)).  Full Article

Dr.Reddy's Laboratories March-qtr consol profit falls
Thursday, 12 May 2016 03:47am EDT 

Dr.Reddy's Laboratories Ltd : March-quarter consol net profit 746 million rupees; March-quarter consol net income from sales and services 37.56 billion rupees . Not got approval from venezuelan government to repatriate amount beyound $4 million recieved during the year . Current outstanding recievable from venezeulan unit up to 3.56 billion rupees presented as exceptional item . recommended final dividend of INR 20 per share .  Full Article

Dr.Reddy's Laboratories Ltd calls out for Paricalcitol capsules lot from US - ASNEWS
Friday, 26 Feb 2016 09:15pm EST 

Dr.Reddy's Laboratories Ltd:Dr Reddy's Laboratories has started recalling some lots of its Paricalcitol Capsules of one mcg, two mcg four mcg strengths from the US markets. - ASNEWS.The company called for actions voluntarily due to reports of breakage and leakage of the capsules.According to a notification put by the US Food and Drug Administration, these lots are recalled under 'Class-III' classification, which was described as a situation in which use of or exposure to a violated product is not likely to cause adverse health consequences.Paricalcitol, a Vitamin-D compound is used for preventing and treating high levels of parathyroid hormone in certain patients.The firm is recalling 24,661 bottles from the market from November last year. These capsules are manufactured at DRL's Bachupally unit in Hyderabad.  Full Article

Dr.Reddy's Laboratories Ltd's Promius Pharma receives FDA Approval for Sernivo (betamethasone dipropionate) Spray, 0.05%
Sunday, 7 Feb 2016 10:37pm EST 

Dr.Reddy's Laboratories Ltd:Says that its US subsidiary, Promius PharmaTM, LLC, U.S, has received approval for Sernivo (betamethasone dipropionate) Spray, 0.05% from U.S. Food and Drug Administration (FDA).Say sSernivo Spray, a prescription topical steroid, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.Says commercial launch of the product is planned for the coming quarter.  Full Article

Dr.Reddy's Laboratories Ltd receives FDA approval for ZEMBRACE SymTouch injection for acute treatment of migraines in adults
Tuesday, 2 Feb 2016 04:38pm EST 

Dr.Reddy's Laboratories Ltd:Receives FDA approval for ZEMBRACE SymTouch injection for acute treatment of migraines in adults.  Full Article

Dr.Reddy's Laboratories Ltd ays USFDA grants extension till Dec 7 for warning letter response
Wednesday, 25 Nov 2015 05:36pm EST 

Dr.Reddy's Laboratories Ltd:Update on USFDA warning letter.Co in process of preparing response to FDA warning letter.FDA has granted an extension until December 7 for submission of response.  Full Article

Dr.Reddy's Laboratories Ltd slumps; US FDA releases details of warning letter - Reuters
Wednesday, 25 Nov 2015 12:22pm EST 

Dr.Reddy's Laboratories Ltd:Dr Reddy's Laboratories' REDY.NS shares slump as much as 8.3 pct - RTRS.Marks its lowest intraday level since Feb.10 - RTRS.US FDA releases details of warning letter (http://1.usa.gov/1QIDDeg) - RTRS.Warning letter details are stringent in tone and scope - analysts - RTRS.Observations about an "uncontrolled custom QC lab previously unknown to the FDA" and "recurrent violations" are particularly worrisome as they go beyond procedural issues - Citi - RTRS.The content of the warning letter for the three manufacturing sites for Dr Reddy's is strongly worded - CLSA - RTRS.Dr Reddy's response to the warning letter would be crucial, failing which there could be an adverse action (import alert) for these sites - CLS - RTRS.  Full Article

Dr.Reddy's Laboratories Ltd - U.S. court imposes temporary sales ban on Dr Reddy's generic Nexium - Reuters
Tuesday, 10 Nov 2015 05:58am EST 

Dr.Reddy's Laboratories Ltd:Dr Reddy's Laboratories Ltd said on Tuesday it had been temporarily barred by a U.S. court from selling its generic form of blockbuster heartburn drug Nexium in the United States - RTRS.The order was passed by the U.S. district court of Delaware after AstraZeneca, the maker of Nexium, moved a motion objecting to the use of the colour purple in the Dr Reddy's copycat product, the Indian firm said in a statement - RTRS.The temporary restraining order has been imposed "with immediate effect on sales, delivery, transfer, or other disposition" of Dr Reddy's generic Nexium, the company said - RTRS.Dr Reddy's launched its generic Nexium in September after weeks of delay, as it had to shift production to a different plant after the U.S. Food and Drug Administration found quality control lapses at the original site - RTRS.  Full Article

Dr.Reddy's Laboratories Ltd's statement on receipt of warning letter from US FDA
Thursday, 5 Nov 2015 11:40pm EST 

Dr.Reddy's Laboratories Ltd:Acknowledged that it has received a warning letter issued by the US FDA dated Nov. 5, relating to its API manufacturing facilities at Srikakulam and Miryalaguda, as well as oncology formulation manufacturing facility at Duvvada, Visakhapatanam.Says this action follows the earlier inspections of these sites by agency in Nov. 2014, Jan. 2015 and Feb. 2015 respectively.  Full Article