Sun pharma receives warning letter for halol facility. Clearance of the warning letter may require another inspection, sun pharmas shanghvi said on the call. 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. Sun pharma was earlier issued a warning letter by the usfda for its halol facility in december 2015. When the us fda finds that a firm has significantly violated fda regulations e. Us fda has given a 14page inspection report on sun pharmas halol plant. Usfda issues warning letter to exsun pharma us facility. Article indian pharma increasing capital and research spending. Indias largest drug maker sun pharma has received a warning letter from the us fda for. The company has been making efforts to make the halol plant cgmpcompliant again. Indias largest drug maker sun pharma has received a warning letter from the us fda for manufacturing lapses at its facility in halol. 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. In december 2016 the fda sent sun a warning letter about nine violations at its manufacturing plant in halol. Sun pharmaranbaxy deal gets noobjection from bse, nse.
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. Article dr reddys slumps as it confirms warning letter from us fda. Learn about the types of warning letters on fdas website. 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. Sun pharmaceuticals halol plant has a history of regulatory. We acknowledge receipt of your additional correspondence of december 12, 2014. Matters described in fda warning letters may have been subject to subsequent interaction between fda and the letter recipient that may. Feb 23, 2018 but new launches were cut off when the fda in 2015 vilified the plant in a warning letter. The warning letter even led the fda in 2015 to revoke approval of a new epilepsy drug developed by biotech sparc for sun. Trouble spots in online directtoconsumer prescription drug.
Sun pharma did not give details on the number and nature. The halol factory makes up 15 percent of sun pharmas u. Last december, the us drug regulatory agency had issued a warning letter to the same site. Reddys warning letter srikakulam, ap api 6nov15 x na dr. Cardinal tips api supply chain to weather impact of coronavirus. Nov 18, 2016 mumbai the us fda has begun its inspection at sun pharma s halol manufacturing facility, considered to be the most crucial for the company, according to three industry sources.
From september 819, 2014, investigators from the u. 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. View sun pharmaceutical industries limiteds fda inspection, warning letter, form 483 observation details related to gmp quality systems on. The indian drugmaker reported pdf over the weekend that an inspection from dec. Usfda issues warning letter to ex sun pharma us facility the philadelphia plant is among the two facilities that sun pharma had sold to frontida biopharm in june this year, along with 15 products, for an undisclosed amount. So you would mean that for the fy16 guidance number or fy15 which is the last reported. Warning letter for halol facility call transcript 06. The ranbaxy acquisition will also drag margins initially though it is expected to bring benefits of scalability in the long run. Fda finds incomplete lab records at sun pharma plant. Sun pharma gets warning letter from usfda newsgram. Draft letter of offer september 15, 2015 for our equity shareholders only sun pharma advanced research company limited our company was incorporated on march 1, 2006 as sun pharma advanced research company limited under the provisions of the companies act, 1956 having registration number 047837 of 2006 with the registrar of companies, ahmedabad, gujarat. By pharma news dcat publisher january 15, 2016 the us food and drug administration fda has posted a warning letter on its website to zhejiang hisun pharmaceutical co. Sun says halol plant cited again by the fda fiercepharma. In the warning letter dated may 7 and posted on the fda website on tuesday, the regulator said sun pharma failed to ensure laboratory records.
Past us fda enforcement action on indian companies. The problem dates back to 2014, when sun first received an fda form 483 for the site, followed shortly thereafter with a formal warning letter, citing serious sterility concerns. The fda issued a second complete response letter for the treatment in 2017. Us fda conducted its first inspection of the facility in 2014 and another in december 2015. Twentyseven 27, 54% of the total, were issued to compounding pharmacies, all located in the us. Sun pharmas stock fell as much as 3 percent to 636. Company fda action unit nature of facility date of action date of resolution resolution in months dr. Briefzhejiang hisun pharma receives warning from u. Dec 20, 2015 sun pharma gets us fda warning for manufacturing lapses tnn updated. 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 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 pharmaceutical industries shares sink on fda warning. Tell a friend print home sun pharma receives warning letter for halol facility.
Sun pharma gets warning letter from usfda the hindu. The fdas intimation for removal of the plant from the official action initiated status will clear the path for sun pharma to supply approved drugs from the plant, subject to normal regulatory requirements. Sun pharma gets us fda warning for manufacturing lapses. Sun house, 201 b1, western express highway, goregaon e, mumbai 400063 for further updates and specific queries, please visit. Sun pharma gets us fda warning for manufacturing lapses tnn updated. Article sun pharma fy 2016 1stqtr hit by ranbaxy integration and other costs. Cardinal predicts api industry should be able to work through. A reinspection in late 2016 was unable to lift the stigma. The sponsor of a proposed drug, usually a pharmaceutical com pany.
While the stock price was factoring in this risk, we. Sun pharma to seek fda reinspection of halol plant by end. Sep 10, 20 when the us fda finds that a firm has significantly violated fda regulations e. Sun pharma hit with warning letter over data issues.
Article sun pharma finally completes ranbaxy acquisition. The fda has issued a warning letter to sun pharmaceutical for its. May 26, 2017 clearance of the warning letter may require another inspection, sun pharmas shanghvi said on the call. Tracking the sun pharma halol plant us fda inspection. 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. 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. Article cadila healthcare gets fda warning, shares plunge 17%. Fda warning letter hits sun pharma for hiding batch failures. 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. Dec 21, 2015 fda slaps sun pharma with warning letter on indian plant. Impact of warning letter sun owns 48 facilities globally, of which 14 are usfda approved formulation facilities. The violation, such as poor manufacturing practices, problems with claims for what a product can do, or. The warning letter even led the fda in 2015 to revoke approval of a new. 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.
Thanks to a slew of quality control problems at one of its key generic manufacturing plants, indias largest drug maker has been under supply restrictions. Fda slaps sun pharma with warning letter on indian plant. Indias largest drugmaker sun pharma gets warning letter. Dec 21, 2015 sun pharmaceutical shares fell as much as 7.
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. Us fda warns sun pharma for violating manufacturing. Sun pharma subsidiary receives fda warning letter 1 min read. Fda issued 50 drug gmp warning letters in calendar year 2015. Us fda ban on sun pharma unit lifted after over 3 years. Food and drug administration fda inspected your pharmaceutical manufacturing facility, sun pharmaceutical industries ltd. Press release sun pharma receives warning letter for halol facility.
Usfda made 9 observations post halol unit inspection. Us regulator warns sun pharma for violating manufacturing. Sun pharma has announced that the fda has issued a warning letter to its facility located at halol, gujarat. Sun pharma says usfda issues at halol over, two specialty. Sun pharmaceutical industries limited fda inspections. Apr 21, 2017 sun pharmas stock fell as much as 3 percent to 636.
The letter followed inspection of the facility in september 2014 by fda inspectors. Global sales of branded generic drugs are expected to progress at 8% cagr through 2029, but the us and europe are not set to drive this growth. While the plant was served warning letter by us regulator in december 2015, product approvals were frozen in september 2014. In addition, sun seems to have taken on a practice whereby it unofficially tests samples and then discards the results while reporting results from other tests. The fdas warning letters and novs, which were issued to pharmaceutical companies over a 10year period 2005 to 2014 regarding online promotional. Press release sun pharma receives eir for halol facility. Sun pharma gets usfda warning letter on halol 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. 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. Our bureau mumbai updated on march 12, 2018 published on may 21, 2014. Sun parmas halol plant received a warning letter last year from the us. The fda has issued a warning letter to sun pharmaceutical for its plant in halol, india, a facility.
Sun pharma consolidated december 2019 net sales at rs 8,154. Dilip sanghvi led sun pharmaceutical industries is yet to see the daylight in the recent reinspection of its halol plant by the united states food and drug administration. But new launches were cut off when the fda in 2015 vilified the plant in a warning letter. Article sun pharmas takeover of ranbaxy comes to attention of competition commission. Ranbaxys stronghold in the fast growing emerging markets 50% of ranbaxys sales will complement suns presence in this space. All injectables for the us are manufactured at this plant including lipodox or gdoxil doxorubicin. Sun pharma receives warning letter for halol facility mumbai, december 19, 2015. Read more about sun pharma says usfda issues at halol over, two specialty drugs may get nod on business standard.
The deficiency from the sun pharmaceuticals warning letter deficiency. Gmp drug warning letters issued in calendar year 2015 data. Mar 12, 2018 sun pharma gets warning letter from usfda. Press release sun pharma receives warning letter for halol. Sun pharma warns new normal will push down its sales. 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. View strides shasun limiteds fda inspection, warning letter, form 483 observation details related to gmp quality systems on. Says receives warning letter from fda over insufficient data on 29 of its active pharmaceutical ingredients api. Sun pharma gets warning letter from usfda for key facility. The action followed over 20 observations that were detected in 2014 as part of us fdas routine inspections.
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