Sun pharmaceutical received a warning letter from the us fda as a result of a september 2014 inspection of the companys facility at halol, gujarat. It had been tagged with a warning letter in 2015 as well. Generic drugs not as safe as fda wants you to believe c. Learn about the types of warning letters on fdas website. Of these, 48% are administered orally or sublingually and 44% are administered by injec tion or infusion. Sun pharmaceutical industries limited fda inspections. Sun pharma receives warning letter for halol facility mumbai, december 19, 2015. Progress at suns halol, india, plant tarnished by new fda. The violation, such as poor manufacturing practices, problems with claims for what a product can do, or. Sun pharmaceutical received a warning letter from the us regulator in december 2015 following an inspection at its halol facility. 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. Mar 12, 2018 sun pharma gets warning letter from usfda. After more than two years of intense effort, sun pharma has returned its key plant to the good graces of the fda.
Wockhardt us plant nailed by fda in a warning letter. Opportunity for production chemists, apply now may 15, 2020 may 2020. Noven pharmaceuticals hit with item form 483 20151023. Zhejiang hisoar pharmaceutical, 816 validation center. Drug major sun pharmaceutical industries today said it has received a warning letter from the usfda over violation of manufacturing norms in its facility at halol in gujarat the warning letter. 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. The fda has issued a warning letter to sun pharmaceutical for its. Press release sun pharma receives warning letter for halol facility. All letters were also downloaded and converted into pdf portable document format. Warning letter for halol facility call transcript 06. Analysis of fda warning letters issued to indian pharmaceutical. Fda warns horizon pharmaceuticals about drug products. Warning letters from us fda to indian mfg sites increased in.
Food and drug administration fda inspected your pharmaceutical manufacturing facility, sun pharmaceutical industries ltd. New drugs 2015 3 new drugs 2015 introduction nearly 100 new drugs were approved in 20 and 2014 for over 50 indications. Fda warns indias lupin over generic drug quality violations. Close out letter 3716 more in 2015 page last updated. Briefzhejiang hisun pharma receives warning from u. Indias largest drugmaker sun pharma gets warning letter. Warning letter certified mail return receipt requested august 25, 2011 wl 5411 maurice j. Sun pharma gets warning letter from usfda over halol unit. We may also refuse admission of articles manufactured at sun pharmaceutical industries ltd. Sun pharmaceutical industries ltd announced that it has received a warning letter from the us fda as a result of the september 2014 inspection, for its facility located at halol, gujarat in india. Zydus cadila in a public filing pdf today says the agency has issued a warning letter for the facility. The food and drug administration fda has issued two warning letters to ranbaxy laboratories ltd and an import alert for generic drugs produced by the companys dewas and paonta.
During the june 22 to july 10 inspection of the transdermal patch makers miami, fla. Fda slaps sun pharma with warning letter on indian plant. Nov 14, 2017 an employee holds ramipril capsules for a photograph inside a coating unit at the lupin ltd. Fda makes 3 observations after sun pharma plant inspection. Indias largest drugmaker sun pharma gets warning letter from. Leading medical device exporting countries worldwide in 2015 in million. Sun pharma gets us fda warning for manufacturing lapses. Sun house, 201 b1, western express highway, goregaon e, mumbai 400063.
Amid ongoing efforts by the us fda to crack down on foreign suppliers not meeting cgmp current good manufacturing requirements, indiabased sun pharma is the latest company to be hit with a warning letter. Fda on its pharma ingredients friday, sep 11, 2015 zhejiang hisun pharmaceutical co ltd says receives warning letter from fda over insufficient data on 29 of its active pharmaceutical ingredients api. 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. Matters described in fda warning letters may have been subject to subsequent interaction between fda and the letter recipient that may. Trouble spots in online directtoconsumer prescription drug. Horizon pharmaceuticals has been warned by the food and drug administration fda to better respond on resolving certain issues it had in its drug manufacturing facilities, that the fda pointed out after an inspection in 2015. Sun pharma sinks 7% on warning letter but analysts bullish. Reflecting these concerns, the uk mhra, who and parenteral drug association pda released fresh guidance documents in 2015 emphasizing data integrity and good record management.
Guidancecomplianceregulatoryinformationguidancesucm070287. Our bureau mumbai updated on march 12, 2018 published on may 21, 2014. From september 819, 2014, investigators from the u. If you need help accessing information in different file formats, see instructions for downloading. Ecr pharmaceuticals, a wholly owned subsidiary of valeant pharmaceuticals international. Fda warns caraco over violations at drug plant law360. 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 pharmaranbaxy deal gets noobjection from bse, nse.
Sun pharma sinks 7% on warning letter but analysts bullish however, most analysts are still bullish on the stock and are keenly waiting to for more details in the warning letter. Similarly, in 2015, 9 out of 10 quality related warning letters issued globally up to august 2015 cited data reliability concerns. Us regulator warns sun pharma for violating manufacturing. Indias largest drug maker sun pharma has received a warning letter from the us fda for manufacturing lapses at its facility in halol. Miller executive director of the carlsbad operations noven pharmaceuticals, inc. Online interviews for freshers may 15, 2020 indswift laboratories ltd. Additionally, the warning letter said sun s operation was aware in april 2015 that benzophenone had leached into felodipine tablets from the ink. South koreas celltrion inc shares fell on thursday after the pharmaceutical company said it had received a warning letter from the u. Article information, pdf download for analysis of fda warning letters issued to indian.
Frontida says it had full knowledge of fda issues of suns. Being free of the restrictions tied to a 2015 warning letter. Sun pharma gets warning letter from usfda the hindu. Sun pharma receives warning letter for halol facility. Sep 11, 2015 says receives warning letter from fda over insufficient data on 29 of its active pharmaceutical ingredients api.
Press release sun pharma receives warning letter for halol. In 2015, facing concerns from investors, sun pharma had to shelve its plans to invest in wind energy project in the us through its subsidiary taro pharma. An fda warning letter was recently issued to a contract testing lab that contained a clear warning indeed. View strides shasun limiteds fda inspection, warning letter, form 483 observation details related to gmp quality systems on. 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. Trends in fda good manufacturing practice warning letters. 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 pharma said in a statement to stock exchanges. The issues first crept up in 2014, and then the plant in 2015 was savaged in a warning letter that found a host of problems including data integrity concerns. The compounding pharmacyoutsourcing facility segment continues to attract disproportionate enforcement attention from fda, receiving more than 50% of the warning.
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. Nda 022363 livalo pitavastatin tablet, for oral use, 9242019. Trouble spots in online directtoconsumer prescription. Sun says halol plant cited again by the fda fiercepharma. 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 pharmaceuticals halol plant has a history of regulatory concerns that.
View sun pharmaceutical industries limiteds fda inspection, warning letter, form 483 observation details related to gmp quality systems on. Fda turns down azs zs9 once again on manufacturing issues. South korean drugmaker slapped with fda warning letter. The number of drug gmp warning letters issued more than doubled over the previous year, from 42 in fy2015 to 102 in fy2016. The warning letter even led the fda in 2015 to revoke approval of a new epilepsy drug. Sep 21, 2017 south korean drug manufacturer firson was slapped with a warning letter and placed on an import alert by the fda in the wake of a plant inspection last november.
Jun 01, 2017 there had been concerns about the cash generated by the pharma business being deployed to fund the new capitalintensive ventures. 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. Sun pharma hit with warning letter over data issues. Sun pharma gets eir for crucial halol plant, us sales to. Warning letter citation noting many deficiencies with laboratory systems and records. Corporate participants dilip shanghvi managing director, sun.
The fda sent a warning letter to the drugmaker on january 10 2017, in which it said that it has failed in preventing. The fdas warning letters and novs, which were issued to pharmaceutical companies over a 10year period 2005 to 2014 regarding online promotional. Food and drug administration fda inspected your drug manufacturing facility, sal pharma, at 171712 bakaram, hyderabad, andhra pradesh, from june 27 to july 1, 2016. Fda warns indias drug maker for violating manufacturing. A reinspection in 2016 produced 14 pages of new observations.
An analysis of trends in drug advertising violations based on. 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. Zydus cadila injectables plant slapped with fda warning letter over. According to sun pharmas 201516 annual report, it is the fifth largest generics company in the us with one of the largest abbreviated new drug applications pipeline and a portfolio of over 400 approved products. The indian drugmaker reported pdf over the weekend that an inspection from dec. Pharmaceutical, directtoconsumer advertising dtca, food and. The fdas warning letters and novs, which were issued to. In 201516, the company earned 48 per cent of its revenue rs,516 crore from the united states market itself. Sep 10, 20 when the us fda finds that a firm has significantly violated fda regulations e. Warning letter cgmpactive pharmaceutical ingredients apis 1231 2015. Indian pharma under pressure with us fda warning letters.
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