Fda finds incomplete lab records at sun pharma plant. Sun pharmaceutical industries hopes of an early resolution of regulatory concerns have suffered a setback with us food and drugs administration issuing a warning letter to its halol plant. Article dr reddys slumps as it confirms warning letter from us fda. Indias largest drugmaker, sun pharmaceuticals, said on saturday that it had received a warning letter from the us food and drug administration, citing violations of good manufacturing practices. Sun says halol plant cited again by the fda fiercepharma. In december 2016 the fda sent sun a warning letter about nine violations at its manufacturing plant in halol. Indias largest drugmaker sun pharma gets warning letter. Zenotech sun pharma multiple positions in microbiology quality control ehs production upstream process.
Sun pharma ltd walkin interviews for multiple positions on. Article cadila healthcare gets fda warning, shares plunge 17%. Sun pharma gets fda warning over halol plant business. May 26, 2017 clearance of the warning letter may require another inspection, sun pharmas shanghvi said on the call.
The attached pdf file contains all software and computer related warning letter excerpts posted on this site for the years listed. Sun pharmaceutical received a warning letter from the us regulator in december 2015 following an inspection at its halol facility. Pdf manufacturers of pharmaceuticals use advertising and promotion as key marketing activities to foster the success of their products. 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. On 19 december 2015 sun pharmaceutical industries announced that it has received a warning letter from the usfda as a result of the september 2014 inspection for its facility located at halol. Indias largest drug maker sun pharma has received a warning letter from the us fda for manufacturing lapses at its facility in halol. Gmp drug warning letters issued in calendar year 2015 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. Sun pharma ltd walkin interviews for multiple positions. Nov 18, 2016 last december, the us drug regulatory agency had issued a warning letter to the same site. Sun pharmaceutical industries limited fda warning letters. Us fda warns sun pharma for violating manufacturing standards. Fda warns sun pharma over standards at halol plant arab news. Fdas warning to sal pharma comes roughly 10 months after the agency inspected the companys hyderabad, india facility in june and july 2016.
The site is amongst the largest for sun pharma and is used to ship multiple formulations to the us. Read more about usfda issues form 483 to sun pharma s dadra plant over quality issues on business standard. Apr 21, 2017 sun pharmas stock fell as much as 3 percent to 636. Indias largest drugmaker sun pharma gets warning letter from. Dec 17, 2015 we may also refuse admission of articles manufactured at sun pharmaceutical industries ltd. Sun pharma gets warning letter from usfda for key facility. Pdf content analysis of fda warning letters to manufacturers of.
Article sun pharma fy 2016 1stqtr hit by ranbaxy integration and other costs. 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. 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. The indian drugmaker reported pdf over the weekend that an inspection from dec. A reinspection in 2016 produced 14 pages of new observations. New fda warning letter, form 483 for two indian companies raps. Sun pharma receives warning letter for halol facility. Warning letter for halol facility call transcript 06. Sun pharmaceuticals halol plant has a history of regulatory. Press release sun pharma receives warning letter for halol. 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.
Dec 21, 2015 the fda has issued a warning letter to sun pharmaceutical for its plant in halol, india, a facility that accounts for about 15% of its u. Links to the warning letter on the fda website are included as well as information regarding. Sun house, 201 b1, western express highway, goregaon e, mumbai 400063 for further updates and specific queries, please visit. Last february, the agency placed the firm on import alert. Indias largest generic drug maker announced today it had. New fda warning letter, form 483 for two indian companies. Sun pharma gets warning letter from usfda newsgram. Fda data integrity findings continue at indian firms. The food and drug administration has issued another warning letter to the company because one of its major manufacturing plants has fallen short on quality control. As a part of the agreement the sun pharma subsidiary has divested this unit as a going concern along with the employees and related products to nostrum. Sun pharmaceuticals industries company history business. Warning letter pharmaceutical laboratories and consultants inc.
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 from the computer. The letter provides eyeopening insights into the integrity lapses and efforts to cover them up that fda has been finding in india. Sun pharmaceutical industries shares sink on fda warning. Gmp drug warning letters issued in calendar year 2015 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. Cipla gets first us fda warning letter ever for goa plant livemint. Us regulator warns sun pharma for violating manufacturing. Indias largest pharma company, sun pharmaceutical industries ltd.
Indias largest pharmaceutical company, sun pharmaceutical, has. 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. A warning letter signifies serious breach of norms at a facility, and the. Fda warns sun pharmaceutical of quality problems the. Zenotech sun pharma multiple positions in microbiology. Shanghvi said the warning letter may have been issued because sun pharma had not effectively communicated to the fda the extent of remediation work it had already done. Sun pharma gets us fda warning for manufacturing lapses. Fda slaps sun pharma with warning letter on indian plant. The fda issued a second complete response letter for the treatment in 2017. Sun pharmaceutical industries limited fda inspections. Article sun pharma finally completes ranbaxy acquisition. The action followed over 20 observations that were detected in 2014 as part of us fdas routine inspections.
Fda makes 3 observations after sun pharma plant inspection. Sun pharmaceutical industries shares sink on fda warning letter. We may also refuse admission of articles manufactured at sun pharmaceutical industries ltd. Dec 21, 2015 the us food and drug administrations us fda warning letter to sun pharma indicates the agency is dissatisfied with the remedial measures the company has implemented since last september, when. View sun pharmaceutical industries limiteds fda inspection, warning letter, form 483 observation. Sun pharma gets warning letter from us fda for its halol. Article indian pharma increasing capital and research spending. Trends in fda good manufacturing practice warning letters.
Bloombergquint accessed the form 483 which was issued by the u. Pharmaceutical guidanace april 20, 2020 comments off on zenotech sun pharma multiple positions in microbiology quality control ehs production upstream process 88 views. Sun parmas halol plant received a warning letter last year from the us fda due to past violations, which prevented new product launches from the facility in the us, the companys largest market. Fda warning letter sun pharmaceutical industries 2014.
Sun pharma receives warning letter for halol facility sun. Sun pharmaceutical industries inc 825 10 department of health and human services public health service food and drug administration waterview corporate center 10 waterview blvd. Article sun pharmas takeover of ranbaxy comes to attention of competition commission. Sun pharmaceutical industries, inc, spi inc a wholly owned. As per media reports, the regulator is learnt to have found deficiencies relating to medicine quality, data collection, maintenance as well as quality control unit. Sun pharma warns new normal will push down its sales next. Read more about sun pharma gets fda warning over halol plant on business standard. Unapproved drugsmisbranded sunmed tincture also referred to as 0. Indias largest drug maker sun pharma has received a warning letter from the us fda for its manufacturing facility based in halol, gujarat.
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. For district office warning letters see the main fda foi warning letters page. Usfda issues form 483 to sun pharmas dadra plant over. Us fda warns sun pharma for violating manufacturing. Us fda finds breaches at sun pharmas halol plant again. Sun pharma gets form 483 with six observations from u. 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. Guidancecomplianceregulatoryinformationguidancesucm070287.
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 gets warning letter from usfda the hindu. Sun pharma receives warning letter for halol facility mumbai, december 19, 2015. The problems the fda noted in its most recent communication are very similar to those named in a letter sent earlier this year. The report further says that since gdufa, 55% of the current good manufacturing practice cgmp related warning letters. Dec 16, 2019 the warning letter even led the fda in 2015 to revoke approval of a new epilepsy drug developed by biotech sparc for sun. Sun pharma warns new normal will push down its sales. Fda warning not heeded by wockhardt wockhardts problems detailed in the july 20 warning letter were based on a sixday inspection of its biotech park facility in waluj, india the previous march ibid. Nda 022363 livalo pitavastatin tablet, for oral use, 9242019. Press release sun pharma receives warning letter for halol facility. Sun pharma subsidiary receives warning letter from usfda. 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. Mar 12, 2018 sun pharma gets warning letter from usfda.
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