May 26, 2017 clearance of the warning letter may require another inspection, sun pharmas shanghvi said on the call. Indias largest drugmaker said on saturday it had received a letter from the fda and. The us fda issued the notice on tuesday with nine inspectional observations after an onsite inspection of sun pharmas halol facility in gujarat. 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. Warning letter for halol facility call transcript 06. Dec 21, 2015 sun pharma shares fall 7% after fda warning. Dec 21, 2015 sun pharmaceutical shares fell as much as 7. Close out letter 3716 more in 2015 page last updated. The fda has issued a warning letter to sun pharmaceutical for its. 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.
Sun pharmaceutical industries limited fda inspections. Clearance of the warning letter may require another inspection, sun pharmas shanghvi said on the call. 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. Fda warning letter hits sun pharma for hiding batch failures. Ns drug factory for knowingly releasing 27 lots of. Cardinal tips api supply chain to weather impact of coronavirus. 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. Sun had expected halol regain compliance last year.
Fda slaps sun pharma with warning letter on indian plant. Sun pharmaceutical industries shares sink on fda warning letter. The average time to warning letter issuance for all drug manufacturer categories, including compounding pharmacies outsourcing facilities, exceeded 12 months in 1hfy2016. Sun pharma receives warning letter for halol facilitydecember 19, 2015. Fda issued a warning letter on may 27, 2015 to vuab pharma, a manufacturer of apis and soliddosage forms located in the czech republic, for cgmp deviations including the distribution of contaminated apis and inadequate data control. Sun pharma gets warning letter from usfda for key facility at. Sun pharma warns new normal will push down its sales next. 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. Indias largest drug maker sun pharma has received a warning letter from the us fda for manufacturing lapses at its facility in halol. Learn about the types of warning letters on fdas website.
We acknowledge receipt of your additional correspondence of december 12, 2014. Rapid mixer granulator is a multipurpose processer equally suitable for high speed dispersion of dry powders, aqueous or solvent granulation, and effervescent products and. Thousands of executives in these and allied organisations find the pharma letter a necessary read to keep them the first to know about current news and events, written whilst the news is fresh and has the greatest impact on commercial decisions. The pharma letter provides accurate, unbiased business information on the worldwide pharmaceutical, generic and biotechnology industries. 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. Indias largest drugmaker sun pharma gets warning letter from. Sun pharma announces divestment of us manufacturing unitdecember 14, 2015. 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 neardoubling of time between inspection and warning letters issued to sites outside the u.
Sun pharma announces us fda filing acceptance of biologics. Sun pharma shares fall 7% after fda warning financial times. 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. Fdas warning to sal pharma comes roughly 10 months after the agency inspected the companys hyderabad, india facility in june and july 2016. The fda replied to caracos letter on december 22, 2008, characterizing caracos response to the warning letter as positive. Laminar air flow laf work station is capable of maintaining a particulate free work area even when operated in an uncontrolled environment. 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. An analysis of recent cder observation warning letter data. 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. Food and drug administration has pulled up a former sun pharmaceutical sun.
Caraco pharmaceuticals, a subsidiary of sun pharma, tuesday said it has received a warning letter from us food and drug administration, or, fda, over the companys manufacturing facility. 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. Sun pharma hit with warning letter over data issues. However, in december it announced it had received a new form 483 after an inspection earlier that month. Batch records indicated significant deviations that the quality unit failed to investigate. Performance qualification laf laminar air flow pharma editor july 29, 2017. In december 2016 the fda sent sun a warning letter about nine violations at its manufacturing plant in halol.
New fda warning letter, form 483 for two indian companies. The fda has issued a warning letter to sun pharmaceutical for its plant in halol, india, a facility. Dec 21, 2015 fda slaps sun pharma with warning letter on indian plant. Tracking the sun pharma halol plant us fda inspection. Matters described in fda warning letters may have been subject to subsequent interaction between fda and the letter recipient that may. Sep 10, 20 when the us fda finds that a firm has significantly violated fda regulations e. We acknowledge receipt of your additional correspondence.
Corporate participants dilip shanghvi managing director, sun. Sun pharmas stock fell as much as 3 percent to 636. Sun pharma gets us fda warning for manufacturing lapses. Fda issues warning letter to api manufacturer biopharm. 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.
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. View strides shasun limiteds fda inspection, warning letter, form 483 observation details related to gmp quality systems on. New fda warning letter, form 483 for two indian companies raps. Sun house, 201 b1, western express highway, goregaon e, mumbai 400063 for further updates and specific queries, please visit. View sun pharmaceutical industries limiteds fda inspection, warning letter, form 483 observation details related to gmp quality systems on. Links to the warning letter on the fda website are included as well as information regarding imposition of import alerts posted on the fda website. Sun pharma gets warning letter from usfda newsgram. Us fda warns sun pharma for violating manufacturing standards. Warning letter cgmpactive pharmaceutical ingredients apis 1231 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. The letter also raised another issue that putz had discussed with caraco managementthe varying sizes of the tablets it producedinstructing caraco to resolve. 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. 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. Incomplete batch documentation falsification of data on batch documentation datatest. Cardinal predicts api industry should be able to work. Fda finds incomplete lab records at sun pharma plant. Sun has been working to address problems at the halol facility since 2015 when it was issued with a warning letter by the us fda. We may also refuse admission of articles manufactured at sun pharmaceutical industries ltd. Remain optimistic of sun pharma halol unit issue resolution.
If you need help accessing information in different file formats, see instructions for downloading. When the us fda finds that a firm has significantly violated fda regulations e. Us fda conducted its first inspection of the facility in 2014 and another in december 2015. Film coating process of tablet in pharmaceutical manufacturing. 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. Data integrity deficiencies january, 2016 the tabulation on pages 454 include full text of data integrity deficiencies identified in fda drug gmp warning letters issued in calendar year 2015. A year after facing insider trading claims, sun pharma now must fight charges it fired two former employees for refusing to market its meds offlabel. Gmp drug warning letters issued in calendar year 2015 data. Apr 21, 2017 sun pharmas stock fell as much as 3 percent to 636.
Sun pharma gets usfda warning letter on halol facility. Us fda issues sun with form 483 after dadra plant inspection. The fda flagged issues with the companys laboratory records. Last february, the agency placed the firm on import alert. Press release sun pharma receives warning letter for halol. The violation, such as poor manufacturing practices, problems with claims for what a product can do, or. 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. 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. Branded generics forecast to double revenues, with us and europe left behind.
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