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Page 7 - Dr Reddy's

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
Updated On : 06 Apr 2017 | 11:35 PM IST

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 may leverage relationship with partners for new US launches
Updated On : 17 Mar 2017 | 1:54 AM IST

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
Updated On : 10 Mar 2017 | 12:34 AM IST

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
Updated On : 06 Feb 2017 | 11:51 PM IST

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

Dr Reddy's Q3 net profit down 19% at Rs 470 crore
Updated On : 04 Feb 2017 | 10:13 PM IST

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
Updated On : 27 Jan 2017 | 4:36 AM IST

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
Updated On : 11 Nov 2016 | 3:38 PM IST

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
Updated On : 06 Sep 2016 | 7:25 PM IST

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
Updated On : 29 Aug 2016 | 3:46 PM IST

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
Updated On : 07 Aug 2016 | 11:41 PM IST

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
Updated On : 26 Jul 2016 | 11:37 PM IST

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

Dr Reddy's completes Rs 1,569.41 crore share buyback
Updated On : 28 Jun 2016 | 4:14 PM IST

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
Updated On : 28 Jun 2016 | 2:10 AM IST

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

Dr Reddy's buys 8 US drugs from Teva, Allergan for $350 million
Updated On : 11 Jun 2016 | 11:14 PM IST

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
Updated On : 09 Jun 2016 | 12:53 PM IST

Dr Reddy's re-draws new drug plan

Unlike in the past, when it tried to produce its own molecule, this time the company is licensing these from abroad

Dr Reddy's re-draws new drug plan
Updated On : 02 Jun 2016 | 11:36 PM IST

Dr Reddy's launches psoriasis treatment spray

A prescription topical steroid approved by the USFDA in February, 2016

Dr Reddy's launches psoriasis treatment spray
Updated On : 01 Jun 2016 | 12:46 PM IST

Dr Reddy's: Weak Q4, uncertainties remain

Venezuelan adjustments hit results. Plants under US scanner; slow India growth; hence, prospects subdued

Dr Reddy's: Weak Q4, uncertainties remain
Updated On : 12 May 2016 | 11:52 PM IST

Dr Reddy's Q4 net down 85% at Rs 75 cr

Provisioning to write down receivables from Venezuela, higher tax expenses and decrease in revenues impacted the company's profits

Dr Reddy's Q4 net down 85% at Rs 75 cr
Updated On : 12 May 2016 | 3:42 PM IST

Dr Reddy's signs US licensing agreement with XenoPort

The drug major will pay an upfront fee of $50 million (Rs 335 crore) to XenoPort

Dr Reddy's signs US licensing agreement with XenoPort
Updated On : 28 Mar 2016 | 12:29 PM IST