Indias largest drugmaker said on saturday it had received a letter from the fda and. Close out letter 3716 more in 2015 page last updated. Past us fda enforcement action on indian companies. 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. 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. A reinspection in late 2016 was unable to lift the stigma. Press release sun pharma receives warning letter for halol facility. In may, sun pharmas another manufacturing facility in karkhadi, also in gujarat, had received a warning letter from the us fda after investigators identified violations of current good manufacturing practice and regulations for finished pharmaceuticals. Sun pharmaceutical industries shares sink on fda warning letter. The pharma letter provides subscribers with daily, uptodate news, business intelligence, comment and analysis for the pharmaceutical, biotechnology and generics sectors of the health care industry, backed by a team of respected writers with many years of experience in the field. Sun pharmaceutical industries limited fda inspections. Dec 21, 2015 sun pharma shares fall 7% after fda warning. 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.
Warning letter for halol facility call transcript 06. Our bureau mumbai updated on march 12, 2018 published on may 21, 2014. 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. Fda issued 50 drug gmp warning letters in calendar year 2015. May 26, 2017 clearance of the warning letter may require another inspection, sun pharmas shanghvi said on the call. Also get sun pharma adv sharestock detailed information on sun pharma adv along with top stories and articles on sun pharma adv during. Inspections, compliance, enforcement, and criminal. Get latest sun pharma adv newsupdates and resultsanalysis. Sun house, 201 b1, western express highway, goregaon e, mumbai 400063 for further updates and specific queries, please visit. The form 483 notice sent by us food and drug administration to sun pharma could shave off indias biggest drugmakers fy18 eps by 26%, analysts estimate the us fda issued the notice on tuesday with nine inspectional observations after an. Ranbaxys stronghold in the fast growing emerging markets 50% of ranbaxys sales will complement suns presence in this space.
Fda finds incomplete lab records at sun pharma plant. Jun 12, 2018 the agency concluded that the inspection is now closed and the issues contained in the warning letter issued in december 2015 have been addressed, sun said in a statement. Sep 11, 2015 says receives warning letter from fda over insufficient data on 29 of its active pharmaceutical ingredients api. Sun pharma warns new normal will push down its sales next. At the conclusion of the inspection, the agency issued a form 483, with three observations.
Us fda descends on sun pharmas halol unit business. When contacted on phone, sun pharma spokesperson declined to comment. Sun pharma finally free of fda restrictions on its key plant in india. Briefzhejiang hisun pharma receives warning from u. Reddys warning letter miryalaguda, tl api 6nov15 x na. 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. Reddys warning letter srikakulam, ap api 6nov15 x na dr. 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 subsidiary receives fda warning letter 1 min read.
Inspections, compliance, enforcement, and criminal investigations. Dec 17, 2015 from september 819, 2014, investigators from the u. Tell a friend print home sun pharma receives warning letter for halol facility. Drugmaker sun pharma says halol plant has gained u. Clearance of the warning letter may require another inspection, sun pharmas shanghvi said on the call. Sun pharma gets warning letter from usfda newsgram. Press release sun pharma receives warning letter for halol. Corporate participants dilip shanghvi managing director, sun. 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. The warning letter even led the fda in 2015 to revoke approval of a new. View sun pharmaceutical industries limiteds fda inspection, warning letter, form 483 observation details related to gmp quality systems on. 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.
Sun pharma gets usfda warning letter on halol facility livemint. Gmp drug warning letters issued in calendar year 2015 data. Sun pharmas stock fell as much as 3 percent to 636. Us fda warns sun pharma for violating manufacturing standards. Sun pharma gets usfda warning letter on halol facility. The merger will help sun pharma to enhance its presence in emerging pharma markets like russia, brazil, south africa and also for better brand building. Sun pharma gets reprieve as fda clears key halol plant. 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. Company fda action unit nature of facility date of action date of resolution resolution in months dr.
In an email to et, sun pharma shared the response that it had sent to stock exchanges when it received the form 483 warning letter after the regulator conducted inspections between february 1023. Indias largest drugmaker sun pharma gets warning letter from. Sun pharma gets warning letter from usfda the hindu. The ranbaxy acquisition will also drag margins initially though it is expected to bring benefits of scalability in the long run. Sun pharma gets us fda warning for manufacturing lapses. 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. But new launches were cut off when the fda in 2015 vilified the plant in a warning letter. While the plant was served warning letter by us regulator in december 2015, product approvals were frozen in september 2014. Sun pharma has finally dug itself out from under the issues piled on it in a 2015 warning letter at this generics plant in gujarat, india. Details of merger in april 2014 the sun pharma took over ranbaxy the deal was set at us 4. Sun pharmaceuticals halol plant has a history of regulatory. Sun pharmas halol unit receives uk regulators clearance. The agency concluded that the inspection is now closed and the issues contained in the warning letter issued in december 2015 have been addressed, sun said in a statement. Sun pharmas issues with halol was started in 2015, as the fda issued a warning letter subsequent to an inspection in september 2014.
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. Sun pharma says usfda issues at halol over, two specialty. Feb 23, 2018 but new launches were cut off when the fda in 2015 vilified the plant in a warning letter. A recently posted warning letter, issued to the pennsylvania site, mentions that sun pharmas quality unit, at the time, had knowingly released 27 lots of various strengths of clonidine hcl tablets, despite evidence that the active pharmaceutical ingredient api used in manufacturing was potentially contaminated. 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. Sun pharma hit with warning letter over data issues.
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. Fda issues warning letter to recently sold sun pharma. Food and drug administration fda inspected your pharmaceutical manufacturing facility, sun. From september 819, 2014, investigators from the u. The fda has issued a warning letter to sun pharmaceutical for its. Read more about sun pharma says usfda issues at halol over, two specialty drugs may get nod on business standard. In may, sun pharma s another manufacturing facility in karkhadi, also in gujarat, had received a warning letter from the us fda after investigators identified violations of current good manufacturing practice and regulations for finished pharmaceuticals. Dec 21, 2015 sun pharmaceutical shares fell as much as 7. Sun pharmaranbaxy deal gets noobjection from bse, nse. Matters described in fda warning letters may have been subject to subsequent interaction between fda and the letter recipient that may have changed the regulatory status of issues discussed in the letter. 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.
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. Sun pharma also said that its board has decided to evaluate a proposal for buyback of equity shares and will hold a meeting on june 23 for the purpose. Issues at sun pharmas halol plant may take 34 months to resolve. The fda has issued a warning letter to sun pharmaceutical for its plant in halol, india, a facility.
Apr 21, 2017 sun pharmas stock fell as much as 3 percent to 636. Dec 21, 2015 fda slaps sun pharma with warning letter on indian plant. Says receives warning letter from fda over insufficient data on 29 of its active pharmaceutical ingredients api. If you need help accessing information in different file formats, see instructions for downloading. Tracking the sun pharma halol plant us fda inspection. 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. Inspections, compliance, enforcement, and criminal investigationsranbaxy laboratories, ltd.
Food and drug administration fda inspected your pharmaceutical manufacturing facility, sun pharmaceutical industries ltd. The indian drugmaker reported pdf over the weekend that an inspection from dec. Sun pharma gets warning letter from usfda for key facility at. Mar 12, 2018 sun pharma gets warning letter from usfda. Sun says halol plant cited again by the fda fiercepharma.
Twentyseven 27, 54% of the total, were issued to compounding pharmacies, all located in the us. Indian pharma under pressure with us fda warning letters. Sun pharma shares fall 7% after fda warning financial times. Fda slaps sun pharma with warning letter on indian plant. The form 483 notice sent by us food and drug administration to sun pharma could shave off indias biggest drugmakers fy18 eps by 26%, analysts estimate the us fda issued the notice on tuesday with nine inspectional observations after an onsite inspection of sun pharmas halol facility in gujar. 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.
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. Sun pharma receives warning letter for halol facility. Sun pharma receives warning letter for halol facility mumbai, december 19, 2015. Indias largest drug maker sun pharma has received a warning letter from the us fda for manufacturing lapses at its facility in halol.