Indias largest drug maker sun pharma has received a warning letter from the us fda for manufacturing lapses at its facility in halol. Trouble spots in online directtoconsumer prescription drug. Dec 21, 2015 fda slaps sun pharma with warning letter on indian plant. Dr reddys gets 8 usfda observations for duvvada injectable site. Jan 24, 2016 learning from fda warning letter trends by michael wienholt, halloran consulting group we read a lot in the trade press about warning letters issued by fda to industry, and our clients often ask us if we discern any trends that might indicate particular areas of focus of fdas wrath.
Sun pharma gets usfda warning letter on halol facility. Jan 05, 2016 by pharma news dcat publisher january 5, 2016 the us food and drug administration fda has issued a warning letter to sun pharmaceutical industries ltd. Sun pharma and rockwell medical enter into licensing agreement for triferic in india. From september 819, 2014, investigators from the u. The fda in its letter dated january 15, 2017 to fleming laboratories, a pharma company in the business of manufacturing and supply of high quality generic active pharmaceutical ingredients apis to the global pharmaceutical industry observed that it has completed an evaluation of the firms corrective actions in response to its warning letter. Last december, the us drug regulatory agency had issued a warning letter to the same site. Us fda warns sun pharma for violating manufacturing. View strides shasun limiteds fda inspection, warning letter, form 483 observation details related to gmp quality systems on. Sun pharma hit with warning letter over data issues. Tell a friend print home sun pharma receives warning letter for halol facility. The action followed over 20 observations that were detected in 2014 as part of us. Download essentials of human anatomy and physiology marieb.
The report further says that since gdufa, 55% of the current. Meeting of the members of sun pharmaceutical industries limited will be held on saturday, 31st october, 2015, at 9. Sun pharma shares fall 7% after fda warning financial times. Dec 19, 2015 the warning to sun pharma is the latest in a series of fda actions over the past year against drug manufacturing plants in india, which supply about 40 per cent of the medicines sold in the united. Recently, sun pharma announced that the us food and drug administration had inspected the formulation facility between november 17 and december 1 and issued a form 483. Dec 21, 2015 sun pharma shares fall 7% after fda warning.
Generic drugs not as safe as fda wants you to believe c. Sun pharma warns new normal will push down its sales next. The action followed over 20 observations that were detected in 2014 as part of us fdas routine inspections. Fda slaps sun pharma with warning letter on indian plant. View sun pharmaceutical industries limiteds fda inspection, warning letter, form 483 observation details related to gmp quality systems on. Apr 21, 2017 sun pharmas stock fell as much as 3 percent to 636. Warning letter for halol facility call transcript 06. Sun pharma receives warning letter for halol facility. The fdas warning letters and novs, which were issued to pharmaceutical companies over a 10year period 2005 to 2014 regarding online promotional. Indias largest drugmaker sun pharma gets warning letter from.
In december 2016 the fda sent sun a warning letter about nine violations at its manufacturing plant in halol. The fda issued notices of objectionable conditions in 2006, 2007, and 2008. Sun pharma gets warning letter from usfda for key facility. Sun pharma has received a warning letter from the us drug regulator usfda over violation of manufacturing norms in its facility at halol in gujarat. Nomura recently, sun pharma announced that the us food and drug administration had inspected the formulation facility between november 17 and december 1 and issued a form 483. Mehta auditorium general education center, maharaja sayajirao university of baroda, near d. Us fda warns sun pharma for violating manufacturing standards. While data suggests that sun pharmas halol unit 432 days and dr reddys 474 days are closer to resolution timeframe, the concern is that the warning letters are not easy to resolve. We may also refuse admission of articles manufactured at sun pharmaceutical industries ltd. In 2000 and 2002 the fda issued warnings to caraco, a michigan pharmaceutical manufacturer, stating that failure to correct violations promptly could result in enforcement action without further notice. Batch records indicated significant deviations that the quality unit failed to investigate.
In addition, sun seems to have taken on a practice whereby it unofficially tests samples and then discards the results while reporting. During 2015, us fda issued 17 warning letter against 7 in the 2014 and major companies like dr reddys laboratories, cadila healthcare, sun pharmaceutical, unimark remedies, micro laboratories were recipient of warning letters or import alerts during 2015. Indian pharma under pressure with us fda warning letters. In february 2011, taro pharmaceuticals resolved the warning letters after a. Press release sun pharma receives warning letter for halol facility. Reddy had received a warning letter in 2015 over data integrity issues, along with others. Sun pharma introduces absorica ld capsules for management of severe recalcitrant nodular acne in the u. Fda finds incomplete lab records at sun pharma plant. Hall, pratapgunj, vadodara390002, gujarat to transact the following business. The firm also strayed from its batch manufacturing instructions, allowing a bulk batch that was outofspecification to get passing results for viscosity and density, the agency said. Warning letters from the fda have increased 5fold from 2015 to 2018, going from. Sun pharma gets warning letter from usfda the hindu. Corporate participants dilip shanghvi managing director, sun. Sun house, 201 b1, western express highway, goregaon e, mumbai 400063 for further updates and specific queries, please visit.
Indias largest drugmaker sun pharma gets warning letter. Sun pharmaceutical industries shares sink on fda warning. Sun pharmaceuticals factory in halol, in the western indian state of gujarat, received a warning letter from the fda, the latest setback for indias pharmaceutical companies. Sun pharma gets warning letter from usfda newsgram. While the stock price was factoring in this risk, we. In december 2016 the fda sent sun a warning letter about nine. Sun pharmaceutical industries shares sink on fda warning letter. Indias largest drugmaker said on saturday it had received a letter from the fda and. Mumbai the us fda has begun its inspection at sun pharmas halol manufacturing facility, considered to be the most crucial for the company, according to three industry sources. Learning from fda warning letter trends med device online. The violation, such as poor manufacturing practices, problems with claims for what a product can do, or. In march 2015, sun pharma announced it had agreed to buy glaxosmithklines.
Sun pharmas stock fell as much as 3 percent to 636. Sun pharma and ranbaxy to merge, create giant pharma co we had managed to get our hands on the warning letter issued by us fda late last year. Sun pharma receives warning letter for halol facility mumbai, december 19, 2015. The fda flagged issues with the companys laboratory records. Drug major sun pharmaceutical industries today said it has. The fda said in its warning letter from earlier this month, which comes as sun has also been issued an import alert over cgmp issues, that sun is missing fundamental raw data and information necessary to document its analyses. The fda has issued a warning letter to sun pharmaceutical for its plant in halol, india, a facility. The report further says that since gdufa, 55% of the current good manufacturing practice cgmp related warning letters. The warning to sun pharma is the latest in a series of fda actions over the past year against drug manufacturing plants in india, which supply about 40 per cent of the medicines sold in the united.
Our bureau mumbai updated on march 12, 2018 published on may 21, 2014. Website, taro pharmaceutical industries is an israeli researchbased pharmaceutical manufacturer. Drug maker dr reddys on october 8 said it got form 483 with 8 observations from us fda for its injectable plant in duvvada. This warning letter includes observations regarding 1 deletion of gc electronic raw data files from the computer, deletion of identically named gc data files, failure to consistently archive data to the central server, 2 software that allowed analysts to delete files. For district office warning letters see the main fda foi warning letters page. Sun pharma to announce third quarter results on 06 february 2020. The warning letter from the usfda will add to the troubles being faced by sun pharma, which has also been weighed down by the integration process with ranbaxy laboratories.
Us regulator warns sun pharma for violating manufacturing. Sun pharma gets warning letter from usfda over halol unit press trust of india december 19, 2015 8. May 26, 2017 clearance of the warning letter may require another inspection, sun pharmas shanghvi said on the call. Dec 19, 2015 dilip shangvi, managing director, expressed consternation that the warning letter, received on friday, had been sent so long after the september 2014 inspection, as he said sun had been working. Sep 10, 20 when the us fda finds that a firm has significantly violated fda regulations e. Dec 17, 2015 from september 819, 2014, investigators from the u. Sun pharmaceutical industries limited fda inspections. Warning letter cgmpactive pharmaceutical ingredients apis 1231 2015. Fda issued 50 drug gmp warning letters in calendar year 2015. Food and drug administration fda inspected your pharmaceutical manufacturing facility, sun pharmaceutical industries ltd. Top 10 fda warning letter findings for finished pharmaceuticals in 2015. Sun pharma warns new normal will push down its sales.
Sun pharma gets us fda warning for manufacturing lapses. Nomura financial advisory and securities india said it remains optimistic of the resolution of the regulatory hurdle at sun pharmaceutical industries halol facility. Tracking the sun pharma halol plant us fda inspection. The deficiency from the sun pharmaceuticals warning letter deficiency. Nov 18, 2016 last december, the us drug regulatory agency had issued a warning letter to the same site. Plants of wockhardt, ipca laboratories remain under the warning letterimport alerts for long now. Learning from fda warning letter trends by michael wienholt, halloran consulting group we read a lot in the trade press about warning letters issued by fda to industry, and our clients often ask us if we discern any trends. The inspection lasted 12 days from the 8 th september to the 19 th september, 2014 while the warning letter was issued only in december, 2015 a complete year later as there were.
Clearance of the warning letter may require another inspection, sun pharmas shanghvi said on the call. Incomplete batch documentation falsification of data on batch documentation datatest. By pharma news dcat publisher january 5, 2016 the us food and drug administration fda has issued a warning letter to sun pharmaceutical industries ltd. Dec 21, 2015 sun pharmaceutical shares fell as much as 7. Remain optimistic of sun pharma halol unit issue resolution. Sun pharmaranbaxy deal gets noobjection from bse, nse. Unapproved drugsmisbranded sunmed tincture also referred to as 0 thc. Fda warning letter sun pharmaceutical industries 2014.
When the us fda finds that a firm has significantly violated fda regulations e. Mar 12, 2018 sun pharma gets warning letter from usfda. Fda warning letter hits sun pharma for hiding batch failures. Sun pharma gets warning letter from usfda for key facility at.
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