Sun pharma receives warning letter for halol facility. Acoalan, antithrombin gamma genetical recombination, july 2015, pdf. The us food and drug administration has issued a from 483 with seven observations to glenmark pharmaceuticals ltd. Sun pharmaceutical industries limited fda inspections. Sun pharma was earlier issued a warning letter by the usfda for its halol facility in december 2015. Food and drug administration fda is shown in silver spring, maryland, november 4, 2009. Us fda warns sun pharma for violating manufacturing standards. In 2008, japanese pharmaceutical company daiichi sankyo acquired a controlling share in ranbaxy and in 2014, sun pharma acquired. In december 2016 the fda sent sun a warning letter about nine violations at. Article indian pharma increasing capital and research spending. Taro pharmaceutical industries is an israeli researchbased pharmaceutical manufacturer publicly listed in the new york stock exchange. Fda issues multiple warning letters addressing data integrity. Indias largest drugmaker sun pharmaceutical industries ltd said it had received a warning letter from the us food and drug administration.
Press release sun pharma receives warning letter for halol facility. Sun pharma, indias largest drug maker on friday said us fda has issued three form 483 observations for its halol site in gujarat. If, as a result of receiving this warning letter or for other reasons, you are considering a decision that could reduce the number of active pharmaceutical ingredients andor finished products. Sun is the latest indian pharmaceutical company to run. The fda issued 85 drug gmp warning letters in cy2018, excluding those issued to compounding. Halol is critical to sun pharma s us business and has been under the warning letter since 2014.
The report further says that since gdufa, 55% of the current good manufacturing practice cgmp related warning letters. In december 2016 the fda sent sun a warning letter about nine violations at its manufacturing plant in halol. While data suggests that sun pharma s 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. Fda warns caraco over violations at drug plant law360. Sun pharma gets reprieve as fda clears key halol plant. Anila mico, director regulatory affairs 29 dunham road billerica, ma 01821. Sun pharma had been earlier issued a warning letter by usfda for its halol facility in december 2015. Here are links to the 2015, 2016, and 2017 installments. The fda has sent a warning letter to zydus cadila, a large indian pharmaceutical company, regarding gmp violations at two of its plantsits moraiya formulation facility and its ahmedabadbased zyfine api facility.
Sun pharma not a pill for the light hearted investor. Sun pharmaceutical industries limited is a leading indian pharmaceutical company engaged in developing. Drug regulator flags seven concerns about glenmarks. Each spring, the fda publishes data on its website related to form 483 inspection observations and warning letters issued by the center for drug evaluation and research cder during the previous fiscal year. Whats worse, sun pharma had offered the plant for reinspection recently after receiving a warning letter in 2015, and completing remediation work. Sun pharma gets vai at halol facility india infoline. In may, sun pharmaceutical, indias largest drug maker, revealed that its u. An analysis of 2018 fda warning letters citing data integrity failures. View sun pharmaceutical industries limiteds fda inspection, warning letter, form 483 observation details related to gmp quality systems on. View strides shasun limiteds fda inspection, warning letter, form 483 observation details related to gmp quality systems on. The companys products are mainly sold in the united states, canada and israel.
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 pharmaceuticals halol plant has a history of regulatory concerns that include repeated form 483s, warning letters and complete response letters for drugs for which it. Us fda finds quality control problems at sun pharmas. Us growth, in turn, was driven by oneoff opportunities of torrent. Leaking ceilings, procedural lapses at sun pharma s halol plant. Data for india and china is even bleaker with just one resolution out of the 64 warning letters issued in past 52 months. These letters are supplied by the cder freedom of electronic information office. Halol approval was already know to the market and attention will now tilt towards the rampup of the specialty business in the us. Firms should map data and process flows and identify and remediate areas of risk.
Sun pharmaceutical halol plant news and updates from the. Drug maker dr reddys on october 8 said it got form 483 with 8 observations from us fda for its injectable plant in duvvada. Sun pharma receives warning letter for halol facilitydecember 19, 2015. Sun pharma subsidiary receives warning letter from usfda. Sun pharma warning letter able labs 31aug10 19sep11 12. Us fda finds breaches at sun pharmas halol plant again.
Last month, fda sent sanofiaventis a warning letter describing violations of current good manufacturing practice regulations that the agency had observed during an inspection of the companys frankfurt am main, germany, facility. Fda issues observations post sun pharma halol plant. Indias largest drugmaker sun pharma gets warning letter. November 18, 2015 monthly update drl warning letter, india slowdown in q2 for q2fy16, the idirect pharma universe ex sun pharma registered yoy revenue growth of 15. Article dr reddys slumps as it confirms warning letter from us fda. Sun pharmaceutical industries, inc, spi inc a wholly owned. Sun pharmaceutical received a warning letter from the us regulator in december 2015 following an inspection at its halol facility. The company has been working on improving processes at halol since fda warned it a year ago. Like our 2015 yearend fda and health care compliance and enforcement. However, the us and indian formulations are by far the core strengths. This standard operating procedure is applicable for pharmaceutical formulation plant.
Sun pharma s us supplies were hit over the past year after the us fda found violations of manufacturing practices at. Online pharmacy warned for selling unapproved covid19 products. Ownership of ranbaxy changed twice over the course of its history. Cadila filed notice of the warning with the bombay stock exchange. An analysis of recent cder observation warning letter data.
In the letter, fda stated that the company had not established or followed appropriate written. Article cadila healthcare gets fda warning, shares plunge 17%. Sun pharma s woes deepen indiabased sun pharmaceutical industries ltd. In march 2015, sun pharma announced it had agreed to buy glaxosmithklines. Sun pharma gets warning letter from usfda over halol unit press trust of india december 19, 2015 8.
For sun, the 2015 warning letter has weighed on sales and added remediation costs as the drugmaker has worked to address the fdas. Us regulator warns sun pharma for violating manufacturing. Sun pharma received 23 observations in september 2014 following which it received a warning letter. Warning letter for halol facility call transcript 06. A reinspection in 2016 produced 14 pages of new observations. Zydus cadila slapped with fda gmp violation letter. Top 10 fda warning letter findings for finished pharmaceuticals in 2015. Warning letter resolutions have become longer and rarer.
The company manufactures and markets a large basket of pharmaceutical formulations in india, the us and several other markets across the world. Pdf mergers and acquisitions in indian pharmaceutical. The letter followed an inspection in september 2014 by fda inspectors. Indias largest drugmaker sun pharma gets warning letter from us fda the warning indicates the agency is not satisfied with the remedial measures sun pharma has been taking at the plant since. Along with ranbaxy laboratories limited acquired in march 2015 in anrating january 2019 amount. Sun pharma recalls more than 216,000 bottles after label.
This page only covers office of prescription drug promotion formerly division of drug. The company has more than 180 of its own drugs sold all over the world, reaching the markets of over 25 countries. Fda makes 3 observations after sun pharma plant inspection. The warning letter even led the fda in 2015 to revoke approval of a new epilepsy drug developed by biotech sparc for sun. Sun house, 201 b1, western express highway, goregaon e, mumbai 400063 for further updates and specific queries, please visit. The warning letter also noted that caracos previous responses to earlier form 483s had been significantly inadequate, and that many current failures of its processes and policies had been previously noted by the fda and not corrected by caraco. Sun pharma warns new normal will push down its sales. Sun says halol plant cited again by the fda fiercepharma. Mccallum was hit with a warning letter from the fda for testing. Fda warns sun pharma over standards at halol plant arab news. The company didnt disclose the nature of these observations.
The stock of sun pharma rose as much as 3 per cent on wednesday tracking the report that the companys halol facility has received an establishment inspection report eir from the. The baddi unit is the finished dosage unit of glenmark and the same was inspected from nov. Established in 1983, sun pharma is the largest indian pharmaceutical company both in terms of market capitalisation and turnover fy15. Partial change approval, paclitaxel, september 2019, pdf.
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