Wockhardts generic version, approved in 2010, is made at the chikalthana, india facility hit by quality issues which resulted in the us. Wockhardt has filed for 43 new generic drug approvals with the u. Usfda gives clean chit to wockhardts chikalthana plant. In may, following an inspection at the manufacturing facility by the us food and drug administration fda, the regulators imposed an import alert, stopping all drugs produced at wockhardts waluj facility in aurungabad, india from entering the us now wockhardt has announced it has received a warning letter, which lists the observations made during the. Wockhardt slumps on drug recall the hindu businessline. We make every effort to prevent errors and discrepancies in the. Wockhardt is a true indian multinational company with a multiethnic workforce of 8600 wockhardt associates from 21 different nationalities globally. The chikalthana facility received 483 observations after the usfda raised several concerns. Wockhardt receives us fda qualified infectious disease product designation for wck 6777, a first ever onceaday. Usfda alert for wockhardts 3rd plant too times of india. Us manufacturing unit of wockhardt under fda scanner the. Food and drug administration fda banned those sites due.
At wockhardt, we are looking at new ways of thinking, new ways of working and new ways to touch peoples lives. Wockhardts chikalthana unit gets us fda import alert. Sep 27, 20 the document, known as an fda form 483, listed 16 socalled observations about wockhardts factory in chikalthana, 200 miles east of mumbai, including concerns about quality control. Fda hits wockhardt us plant for using same bad tests as in. Food and drug administration had raised fresh concerns about a plant already banned from exporting. Wockhardt uk specialises in the manufacture and supply of generic and branded medicines, with a constantly growing portfolio of over 350 product lines. The fda has banned imports from the waluj plant since may 20 over concerns related to manufacturing practices. Wockhardts waluj plant approved by us fda oneindia news. There has been news in certain quarters of the market around fda inspection on one of our sites and the receipt of 483s. The usfda email said, as you can see from yesterdays import alert, that wockhardt location is still actively listed on the import alert. Indian drugmaker wockhardt says fda raised new concerns. The latest fda action against wockhardts chikalthana plant in western india, one of its key export facilities, comes amid a slew of regulatory rebukes in recent months, which has wiped off nearly. Usfda issues warning letter to wockhardts uk facility the. Aug 07, 2017 wockhardt gets us fda approval for antibiotic injection, oxacillin.
Wockhardt enters the us market with zithromax fiercebiotech. In an inspection last month of wockhardts chikalthana plant near aurangabad, the fda made some observations regarding batches of some products manufactured before the facility was banned. Food and drug administration banned imports from one of the plants of indian drug maker wockhardt, in the latest example of increased. Aralez encouraged by generic quality issues in az deal for. The observation is one of a dozen cited in a form 483 the fda has issued to. Wockhardt to recall drugs from plants with us import alert. Wockhardt extended overnight losses and fell over 11% in intraday trade as the company announced it is recalling some drugs from the us markets that were manufactured at its chikalthana plant in aurangabad. Fda investigators audited the wockhardt aurangabad, india facility and issued 16 inspectional observations via fda 483 on 31. The fda does not publicly disclose the results of its inspections or give details about its observations. We acknowledge that the fda has carried out an inspection at our eou injectable units in aurangabad and has issued 483s to us. Us manufacturing unit of wockhardt under fda scanner by ab wire may 27, 2014 12.
Violations observed during the inspection included deficiencies in sterile manufacturing and data integrity. Indias wockhardt has received an fda warning letter for a plant in the u. Nov 24, 2016 over the past few years, wockhardt has been pummelled by the us fda for deviations at its manufacturing sites. Wockhardt is fully committed to follow strong quality cgmp system. The drug price and competition act hatchwaxman act requires fda to publish approved drug products with therapeutic equivalence evaluations, commonly known as the orange book the orange book identifies drug products approved on the basis of safety and effectiveness by the food and drug administration fda under the federal food, drug, and cosmetic act. Wockhardt plunges 14% as usfda issues import alert on. Fda sent a warning letter to wockhardt limited on dec.
Its formulations units in waluj and chikalthana were placed under the import alert since 20, while a similar decision was communicated in august this year for its bulk drugs site at ankleshwar. The orange book downloadable data files are updated. Apr 28, 2015 in an inspection last month of wockhardts chikalthana plant near aurangabad, the fda made some observations regarding batches of some products manufactured before the facility was banned. The wockhardt factories located at waluj and chikalthana in aurangabad district of maharashtra had halted exports to the us, a market that contributed at least 30% of its revenue in fiscal 2011. The us fda has sent indian drugmaker, wockhardt, an import alert notifying that the import of all drugs manufactured at its aurangabad production unit in india have been banned. Fda slams us wockhardt plant with 483 expert briefings.
Wockhardt has filed for 43 new generic drug approvals with the us regulator from its plants in waluj and chikalthana, both of which have now been banned from shipping drugs to. The us food and drug administration fda has approved wockhardt s cephalosporin injectables plant at waluj in aurangabad. Approved drug products with therapeutic equivalence. Patent listings and use codes are provided by the drug application owner, and the fda is obliged to list them. Wockhardt has filed for 43 new generic drug approvals with the us regulator from its plants in waluj and chikalthana, both of which have now been banned from shipping drugs to the us. The fda on friday added wockhardts bulk manufacturing plant in ankleshwar, india, to its import alert list, joining plants in waluj and chikalthana that the fda banned in 20. Isavuconazonium is a secondgeneration triazole antifungal approved on march 6, 2015 by the fda for the treatment of invasive aspergillosis and invasive mucormycosis, marketed by astellas under the brand cresemba. The fda import ban on the chikalthana facility excludes five products, but includes toprol generic. Wockhardt says fda raises new concerns about waluj plant. Wockhardt gets us fda approval for antibiotic injection, oxacillin. The remedial steps for chikalthana and ankleshwar plants will start only after waluj. It has also imposed a similar ban on another wockhardt plant in chikalthana, western india.
Urine spills staining image of wockhardts generic drugs. This report displays final approvals and tentative approvals of original and supplemental applications for the two weeks beginning on the earliest date listed below. More alarm for wockhardt, fda raises concern over us unit. Us fda issues import alert on wockhards chikalthana plant. In another setback to troubled pharma company wockhardt, the us food and drug administration fda has imposed an import alert on its manufacturing unit at chikalthana, aurangabad, in maharashtra. Nonus country and region specific information is not available on this page.
Wockhardt pharmas chikalthana facility in maharashtra recently underwent a 10 daylong inspection by the usfda. As of august 2015, indias generic pharma manufacturer wockhardt ltd. View wockhardt limiteds fda inspection, warning letter, form 483 observation details related to gmp quality systems on. Indian drugmaker wockhardt says fda raised new concerns about. Wockhardt receives fda warning letter pharmaceutical technology. The stateoftheart biotech plant in aurangabad has six dedicated manufacturing facilities for biopharmaceutical bulk as well as recombinant formulations. Wockhardt receives us fda approval for antibiotic injection.
The mumbaibased wockhardt is recalling the remaining batches of drugs in the us that were made before the food and drug administration fda there issued import alerts on its waluj and chikalthana plants in maharashtra. The company said us patients currently using these drugs were at no risk. After its chikalthana and waluj factories were stopped from shipping to the us, the companys biggest market, last year. Dec 23, 2019 in essence, the fda orange book is the foundation of the fda. Wockhardts two key facilities located at chikalthana and waluj, which cater to its us business, came under the us drug regulators scanner in. Nov 27, 20 us fda issues import alert on wockhards chikalthana plant. The orange book downloadable data files are updated monthly. Highly skilled technicians operate 14 manufacturing facilities that are us fda, uk mhra and emea compliant sites in india, the us and europe. New and innovative business models are in motion to make the most of emerging opportunities. Exec says fda issued observations on its us units production process wockhardt bse. The united states is wockhardts biggest market and the fda has already banned the import of generic drugs from its two plants in india, citing quality lapses in the manufacturing process.
Wockhardt plunges as firm to recall drugs from us market. Wockhardt usa llc manufactures, markets andor distributes more than 68 drugs in the united states. Fda hits wockhardt us plant for using same bad tests as in india. Fda nails a third wockhardt plant with a warning letter. Aralez encouraged by generic quality issues in az deal for heart drug. He also said that wockhardt is complying with the fda as best it can. Indias wockhardt to recall some drugs made in india after u. Due to the violations, fda placed the company on import alert 6640 on.
Wockhardts chikalthana plant still under import alert. This will negatively impact the companys us business as its two other facilities at waluj and chikalthana are still under regulatory scanner. Wockhardt shares fall after fda ban on chikalthana plant. Shendra is key to wockhardt s us plans, as the companys plants in waluj near aurangabad and chikalthana also in maharashtra already face import bans in the us. The fda orange book is updated daily as new drugs are approved. Indias wockhardt continues drug recalls after usfda concerns. Fda issued a warning letter to wockhardt limited on 71820 for a previous inspection. Usfda issues warning letter to wockhardts uk facility. Fda issued a warning letter to wockhardt limited on 112520 as a result of this inspection. Shares of pharmaceutical major wockhardt plunged nearly 14 per cent in early trade on reports that the usfda has issued import alert on the companys chikalthana plant.
Jul 18, 20 in addition, your failure to correct these violations may result in fda continuing to refuse admission of articles manufactured at wockhardt limited located at biotech park, plot h142, m. Aug 06, 2016 usfda alert for wockhardt s 3rd plant too. Indias wockhardt to recall some drugs made in india after. Wockhardt gets us fda approval for antibiotic injection. Over the past few years, wockhardt has been pummelled by the us fda for deviations at its manufacturing sites. This is the companys second plant in india to get import alert after waluj.
It is a global company with more than half of its revenue coming from europe. Nov 27, 20 the latest fda action against wockhardt s chikalthana plant in western india, one of its key export facilities, comes amid a slew of regulatory rebukes in recent months, which has wiped off nearly. Medications listed here may also be marketed under different names in different countries. Food and drug administration banned imports from one of the plants of indian drug maker wockhardt, in the latest example of increased global scrutiny of indian generic drug makers. Wockhardt chikalthana, fei 3002808503, was issued a warning letter on november 25, 20, and was placed on import alert on november 26, 20 for, among other things, manipulating and deleting data. Wockhardt uk limited ash road north wrexham industrial estate wrexham, ll 9uf wales. In a bid to end speculation regarding the clearance of the chikalthana plant, the us fda in an official email have written to et now said that the plant is not yet cleared and still under the import alert. Managing director murtaza khorakiwala said on tuesday wockhardt had responded to the fdas observations but declined to give details. Official announcement from the fda is expected in couple. Wockhardt receives us fda warning letter for indian plant. Feb 12, 2008 wockhardt enters the us market with zithromax gets us fda nod to launch generic version of the broadspectrum antibiotic mumbai, 12 feb,2008 pharmaceutical and biotechnology major wockhardt will be.
The us food and drug administration fda has approved wockhardts cephalosporin injectables plant at waluj in aurangabad. Both versions have been discontinued in the us, according to the fdas orange book. Feb 26, 2015 shares in wockhardt ltd fell as much as 5. Indian generic drugmaker wockhardt ltd said on tuesday it would recall some drugs manufactured at its two plants in india before the u. It has 3 research centres and 12 manufacturing plants, with businesses ranging from the manufacture and marketing of pharmaceutical and biopharmaceutical formulations, active pharmaceutical. This is the second plant in india to get import alert. The document, known as an fda form 483, listed 16 socalled observations about wockhardts factory in chikalthana, 200 miles east of. In april 2012, officials from the us fda had conducted an inspection at oneofthethree manufacturing units owned by. The fda has lashed out at indias wockhardt, saying a plant in the u.
The chikalthana facility had received 483 observations after the us food and drug administration fda and the uk medicines and. Wockhardt receives fda warning letter pharmaceutical. The us food and drug administration fda has given a clean chit to the chikalthana plant of wockhardt, reports cnbc awaaz quoting sources. Wockhardt s generic version, approved in 2010, is made at the chikalthana, india facility hit by quality issues which resulted in the us fda issuing an import alert in 20, banning the drug from entering the us meanwhile, novartis subsidiary sandoz recalled its generic version of the drug in 2008 following problems with validating manufacturing processes at its plant in. Feb 26, 2015 the fda has banned imports from the waluj plant since may 20 over concerns related to manufacturing practices. However, fda has excluded five products from import alert. Our products cover many therapy areas including anticoagulation, pain management, antiinfectives, diabetes and antibiotics. Finally, the orange book lists patents that are purported to protect each drug. A new drive for growth today permeates every mindset, process and technoinnovation within wockhardt. Wockhardt to raise inr 1,850 crore by sale of part of portfolio of its domestic branded business. Jan 23, 2018 wockhardts two key facilities located at chikalthana and waluj, which cater to its us business, came under the us drug regulators scanner in 20, following product quality and data.
Wockhardt enters the us market with zithromax gets us fda nod to launch generic version of the broadspectrum antibiotic mumbai, 12 feb,2008 pharmaceutical and biotechnology major wockhardt will be. The company has manufacturing plants in india, uk, ireland, france and us, and subsidiaries in us, uk, ireland and france. Wockhardt, which has been under the usfdas scanner, today said that the american health regulator has completed the inspection of its. Current usfda concerns include questions on the validity of drug testing. It is the prodrug form of isavuconazole, the active moiety, and it is available in oral and parenteral formulations. In addition, your failure to correct these violations may result in fda continuing to refuse admission of articles manufactured at wockhardt limited located at. India plants, waluj and chikalthana aurangabad, maharashtra, as an abundant. Mar 02, 2017 indias wockhardt has received an fda warning letter for a plant in the u. Addressing a press conference at noon, habil khorakiwala, chairman, said. Fda investigators audited the wockhardt aurangabad, india facility and issued 4 inspectional observations via fda 483.
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