Zydus cadila injectables plant slapped with fda warning letter over. 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. Close out letter 3716 more in 2015 page last updated. Nda 022363 livalo pitavastatin tablet, for oral use, 9242019. Learn about the types of warning letters on fdas website. 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. Zydus cadila in a public filing pdf today says the agency has issued a warning letter for the facility.
Progress at suns halol, india, plant tarnished by new fda. Online interviews for freshers may 15, 2020 indswift laboratories ltd. Fda makes 3 observations after sun pharma plant inspection. 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. Matters described in fda warning letters may have been subject to subsequent interaction between fda and the letter recipient that may. 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. Sep 10, 20 when the us fda finds that a firm has significantly violated fda regulations e.
The compounding pharmacyoutsourcing facility segment continues to attract disproportionate enforcement attention from fda, receiving more than 50% of the warning. Corporate participants dilip shanghvi managing director, sun. The warning letter even led the fda in 2015 to revoke approval of a new epilepsy drug. Being free of the restrictions tied to a 2015 warning letter. 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. Similarly, in 2015, 9 out of 10 quality related warning letters issued globally up to august 2015 cited data reliability concerns. Warning letter cgmpactive pharmaceutical ingredients apis 1231 2015. Sun house, 201 b1, western express highway, goregaon e, mumbai 400063. Nov 14, 2017 an employee holds ramipril capsules for a photograph inside a coating unit at the lupin ltd. Fda warns horizon pharmaceuticals about drug products. Article information, pdf download for analysis of fda warning letters issued to indian. Analysis of fda warning letters issued to indian pharmaceutical.
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. Fda warns caraco over violations at drug plant law360. Additionally, the warning letter said sun s operation was aware in april 2015 that benzophenone had leached into felodipine tablets from the ink. 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. Zhejiang hisoar pharmaceutical, 816 validation center. Indian pharma under pressure with us fda warning letters.
Sun pharmaranbaxy deal gets noobjection from bse, nse. In 201516, the company earned 48 per cent of its revenue rs,516 crore from the united states market itself. Fda turns down azs zs9 once again on manufacturing issues. 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. If you need help accessing information in different file formats, see instructions for downloading. Our bureau mumbai updated on march 12, 2018 published on may 21, 2014. Press release sun pharma receives warning letter for halol facility. The fda sent a warning letter to the drugmaker on january 10 2017, in which it said that it has failed in preventing. Noven pharmaceuticals hit with item form 483 20151023. Sun pharma gets warning letter from usfda the hindu. Opportunity for production chemists, apply now may 15, 2020 may 2020. Sun pharmaceutical industries limited grow your pharma.
Sun pharma hit with warning letter over data issues. Leading medical device exporting countries worldwide in 2015 in million. Sun pharma sinks 7% on warning letter but analysts bullish. Warning letter citation noting many deficiencies with laboratory systems and records. 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.
An analysis of trends in drug advertising violations based on. 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 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. 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. Sun pharmaceutical received a warning letter from the us regulator in december 2015 following an inspection at its halol facility. Fda slaps sun pharma with warning letter on indian plant. Sun pharma gets warning letter from usfda over halol unit. Wockhardt us plant nailed by fda in a 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.
The indian drugmaker reported pdf over the weekend that an inspection from dec. South korean drugmaker slapped with fda warning letter. 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. 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. Miller executive director of the carlsbad operations noven pharmaceuticals, inc. South koreas celltrion inc shares fell on thursday after the pharmaceutical company said it had received a warning letter from the u. Warning letter citing lack of adequate controls for a laboratory system, including issues with user accounts, data deletion, and audit trails. 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. Generic drugs not as safe as fda wants you to believe c. Sun pharma receives warning letter for halol facility. View sun pharmaceutical industries limiteds fda inspection, warning letter, form 483 observation details related to gmp quality systems on.
Trends in fda good manufacturing practice warning letters. Fda warns indias drug maker for violating manufacturing. Press release sun pharma receives warning letter for halol. During the june 22 to july 10 inspection of the transdermal patch makers miami, fla. Sun pharma gets eir for crucial halol plant, us sales to. 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. Indias largest drugmaker sun pharma gets warning letter. Jun 01, 2017 there had been concerns about the cash generated by the pharma business being deployed to fund the new capitalintensive ventures. From september 819, 2014, investigators from the u. A reinspection in 2016 produced 14 pages of new observations. Of these, 48% are administered orally or sublingually and 44% are administered by injec tion or infusion.
The fdas warning letters and novs, which were issued to pharmaceutical companies over a 10year period 2005 to 2014 regarding online promotional. Trouble spots in online directtoconsumer prescription. Frontida says it had full knowledge of fda issues of suns. Guidancecomplianceregulatoryinformationguidancesucm070287. Mar 12, 2018 sun pharma gets warning letter from usfda. It had been tagged with a warning letter in 2015 as well. Pharmaceutical, directtoconsumer advertising dtca, food and. 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. Sun pharmaceutical industries limited fda inspections.
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. 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. View strides shasun limiteds fda inspection, warning letter, form 483 observation details related to gmp quality systems on. 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. 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. All letters were also downloaded and converted into pdf portable document format. 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. New drugs 2015 3 new drugs 2015 introduction nearly 100 new drugs were approved in 20 and 2014 for over 50 indications.
Sun pharma gets us fda warning for manufacturing lapses. An fda warning letter was recently issued to a contract testing lab that contained a clear warning indeed. Sun says halol plant cited again by the fda fiercepharma. After more than two years of intense effort, sun pharma has returned its key plant to the good graces of the fda.
Sun pharmaceuticals halol plant has a history of regulatory concerns that. Briefzhejiang hisun pharma receives warning from u. Sep 11, 2015 says receives warning letter from fda over insufficient data on 29 of its active pharmaceutical ingredients api. Food and drug administration fda inspected your pharmaceutical manufacturing facility, sun pharmaceutical industries ltd. The number of drug gmp warning letters issued more than doubled over the previous year, from 42 in fy2015 to 102 in fy2016. The violation, such as poor manufacturing practices, problems with claims for what a product can do, or. The remaining 8% includes drug products that are administered by inhalation, into the ear, and topically. Warning letters from us fda to indian mfg sites increased in. Us regulator warns sun pharma for violating manufacturing. Sun pharma receives warning letter for halol facility mumbai, december 19, 2015. Trouble spots in online directtoconsumer prescription drug. The fda has issued a warning letter to sun pharmaceutical for its.
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