Jan 28, 2016 fda finds indian drug maker wockhardt hid failed tests. Us fda issues warning letter to wockhardts ankleshwar plant. Wockhardts chikalthana unit gets us fda import alert. The us fda uses untitled letters for violations that are not as significant as those that trigger warning letters. An agency spokeswoman told us wockhardt shendra, fei 3009278506, received an untitled letter on january 27, 2017, for manipulating and deleting data and poor aseptic practices in the manufacture of sterile drugs.
Wockhardt ltds stepdown unit in the us, morton grove pharmaceuticals inc. Due to the violations, fda placed the company on import alert 6640 on. Mar 02, 2017 indias wockhardt has received an fda warning letter for a plant in the u. Us fda warning letter to wockhardt bad news capital orbit. Wockhardt receives us fda approval for antibiotic injection. Shares of wockhardt pharma slipped about 3 per cent in fridays trade after us drug regulator found a series of violations at its shendra plant during inspections carried out earlier this month. Brands listed with corresponding generic name and price details. Food and drug administration banned imports from one of the plants of indian drug maker wockhardt, in the latest example of increased. E11, midc shendra, aurangabad district, 431201 maharashtra. Since inception, wockhardts business has increased in. Feb 01, 2016 fda hands wockhardt and ipca more disappointing news.
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. On march 18, 20, an fda investigator identified the presence of torn raw data records in the waste area and asked one of your firms qa officers to remove these torn raw data records for. As it is a small company, people just out of college or trying to change industry get lots of opportunities to learn and familiarize with systems and tools and develop skills for their own professional growth in a pharmaceutical environment. Wockhardt the decision was based on the evaluation by usfda of its preclinical and clinical data of phase i establishing safety and clinical scope of efficacy for the drug. Apr 03, 2017 usfda okays abridged clinical trial for antibiotic. Wockhardt to toe us fda line on shendra unit business. Usfda makes 9 observations over wockhardts plant in shendra the company, whose shares slumped 15. Wockhardt gets us fda approval for antibiotic injection, oxacillin. It had sought approval for 15 products which it proposes to manufacture from shendra for that market. Wockhardt receives acknowledgement of its breakthrough.
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 receives anda approval for pain medication. Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other. Wockhardt uk specialises in the manufacture and supply of generic and branded medicines, with a constantly growing portfolio of over 350 product lines. 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. Fda hits wockhardt us plant for using same bad tests as in. Now, wockhardt must come up with a plan and tell the fda how it will deal with the deficiencies. The company has manufacturing plants in india, uk, ireland, france and us, and subsidiaries in us, uk, ireland and france. Wockhardt chairman habil khorakiwala said the company will be able to make the facility compliant for half the issues in next fifteen days.
It is a global company with more than half of its revenue coming from europe. Wockhardt falls more than 10% on reports over us fda. Food and drug administration fda banned those sites due. Sun pharma and wockhardt have separately initiated voluntary recall of a number of drugs from the us market due to different reasons. 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 hits wockhardt us plant for using same bad tests as in india. Wockhardt limited 718 food and drug administration. Wockhardt says hpra has recommended gmp cert renewal for. The plant is fully automated to provide high quality injectable products. Aug 07, 2017 wockhardt gets us fda approval for antibiotic injection, oxacillin.
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. Mumbai, india, april 3, 2017 prnewswire in a recent meeting between the wockhardt research team and the us fda new drug antibiotic regulatory team, the us fda agreed to an abridged phase iii. Wockhardt is a global pharmaceutical and biotechnology organisation, providing affordable, highquality medicines for a healthier world. Usfda did not find issues at wockhardts chikalthana. Fda investigators audited the wockhardt aurangabad, india facility and issued 4 inspectional observations via.
Food and drug administration fda inspected your drug manufacturing facility, morton grove pharmaceuticals, inc. Usfda observations for shendra facility not critical. The observation is one of a dozen cited in a form 483 the fda has issued to. The fda has already barred import from wockhardt s waluj and chikhalthana units these two and shendra are all within 20 km of aurangabad and the company plans to use the shendra plant to export products to the us. 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. Fda sent a warning letter to wockhardt limited on dec. Usfda issues warning letter to wockhardts uk facility.
Drugmaker wockhardts pending regulatory issues with us food and drug adminstration is getting murkier as the latest observations made by the us drug regulator suggests the indian drugmaker has. Medications listed here may also be marketed under different names in different countries. May 27, 2014 if the fda is not satisfied with the response, it could ban production from its chicagobased morton grove pharmaceuticals unit, which accounts for more than 50 percent of wockhardts sales in the united states, a region that contributed 45 percent to its sales in the fiscal year ended march. Fda inspectors uncovered nine gmp violations at the companys sterile and nonsterile manufacturing facility in shendra aurangabad, according to a form 483 issued after a january inspection. Indias wockhardt gets us fda nod for lisinopril reuters. Usfda issues warning letter to wockhardts uk facility the. Fda alleges deleted files, hidden data at indias wockhardt. You might want to read these first if you have not read them before. Drug maker wockhardt will be offering its waluj facility near aurangabad, maharashtra in early 2018 for us fda inspection. Upon inspection of wockhardts shendrabased facilities, fda employees found evidence of ina ccurate recordkeeping, deleted records and improp erly labeled and filed pharmaceutical ingredients. United states food and drug administration usfda wockhardt news on indian pharmaceutical industry growth. Jan 28, 2016 upon inspection of wockhardt s shendra based facilities, fda employees found evidence of ina ccurate recordkeeping, deleted records and improp erly labeled and filed pharmaceutical ingredients. Now wockhardt has announced it has received a warning letter, which lists the.
The fda has already barred import from wockhardts waluj and chikhalthana units these two and shendra are all within 20 km of aurangabad and the company plans to use the shendra plant to export products to the us. The stateoftheart lyophilisation unit at shendra, aurangabad in india, is a first of its kind in asia. Wockhardt receives fda warning letter pharmaceutical. Two of wockhardts eight plants in india have had export bans placed on them by the u. Fda finds indian drug maker wockhardt hid failed tests reuters. In a note to bse, wockhardt said there is no business being conducted from cp pharmaceuticals in the us market.
Wockhardt has received approval from the us health regulator for its generic oxacillin injection used for the treatment of bacterial infections. Us manufacturing unit of wockhardt under fda scanner the. Violations observed during the inspection included deficiencies in sterile manufacturing and data integrity. Usfda makes 9 observations over wockhardts plant in shendra. Wockhardt to offer its waluj formulation facility for us fda.
The us fda issued a warning letter to wockhardts stepdown indirect subsidiary cp pharmaceuticals in uk, marking a prolonged phase of adverse news related to the drug makers global manufacturing facilities. 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. Jan 12, 2016 wockhardt fda inspection 483, jan 2016 fdazilla. Wockhardt clarified that the inspection was a follow up of the inspection by the us fda as an outcome of completion of good manufacturing practices gmp remediation submitted in october 2014. Fda charges data integrity issues in wockhardt factories. Usfda okays abridged clinical trial for antibiotic. Fda hands wockhardt and ipca more disappointing news. An fda inspection uncovered a host of gmp deficiencies at a wockhardt production plant in india, despite earlier attempts by the company to downplay the findings.
Wockhardt limited b152, midc waluj, maharashtra 4316, india. View wockhardt limiteds fda inspection, warning letter, form 483 observation details related to gmp quality systems on. The usfda has made nine observations highlighting violations of its norms at homegrown drug maker wockhardt s new facility at shendra in aurangabad. Wockhardt limited 57, kunjhal, barotiwala nalagarh, district solan. 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. Approved drug products with therapeutic equivalence. Reacting to the development, the stock saw its value dip 2. However, fda has excluded five products from import alert. Wockhardt limited created its us subsidiary wockhardt usa in early 2004 with a modest portfolio of three fdaapproved generic products.
In april 2012, officials from the us fda had conducted an inspection at oneofthethree manufacturing units owned by. This ban results in detention without physical examination of drugs from firms that have not met socalled good manufacturing practices gmp. Wockhardts india plant hit with form 483 over gmp violations. I had earlier written about wockhardt on two occasions wockhardt stock analysis and why did i sell wockhardt. Wockhardt slips about 3% as usfda issues form 483 the. Wockhardts ankleshwar facility gets new us fda warning letter.
Wockhardt limited fda inspections form 483 warning. Indian generic drugmaker wockhardt ltd said on tuesday it would recall some drugs manufactured at its two plants in india before the u. Usfda makes 9 observations over wockhardts plant in. The company was issued form 483 from the fda at that point and had started working on remedial measures. Our products cover many therapy areas including anticoagulation, pain management, antiinfectives, diabetes and antibiotics. The us food and drug administration us fda issued a warning letter to wockhardt for violating current good manufacturing practice norms, including its failure to ensure proper clothing for workers at its ankleshwar plant in gujarat. Wockhardt limited brand list that includes tablets, capsules, syrups, etc. Wockhardt gets us fda approval for antibiotic injection. In april 2012, officials from the us fda had conducted an inspection at oneofthethree manufacturing units owned by wockhardt, which is indias ninth biggest pharmaceutical company. Indias wockhardt has received an fda warning letter for a plant in the u. Usfda makes 9 observations over wockhardt s plant in shendra the company, whose shares slumped 15. Wockhardt usa llc manufactures, markets andor distributes more than 68 drugs in the united states. Wockhardt to offer its waluj formulation facility for us. Approved drug products with therapeutic equivalence evaluations.
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. Fda finds indian drug maker wockhardt hid failed tests. Fda slams us wockhardt plant with 483 expert briefings. On march 18, 20, an fda investigator identified the presence of torn raw data records in the waste area and asked one of your firms.
Wockhardt receives us fda warning letter for indian plant. Fda investigators audited the wockhardt shendra aurangabad, india facility and issued inspectional observations via fda 483 on 12 jan 2016. Indias wockhardt to recall some drugs made in india after. Usfda wockhardt news on indian pharmaceutical industry. Jul 24, 20 this article talks of the us fda warning letter that wockhardt has received on 18 july 20. Usfda wockhardt news on indian pharmaceutical industry 24thjun2017. Nonus country and region specific information is not available on this page. New product launch approvals of wockhardt are going to be delayed as a second plant operated by the generic drug maker was hit by the us fda import alert. As the demand for contract manufacturing grows, wockhardt continues to upgrade its worldclass facilities and make further investments in new units and processes. More alarm for wockhardt, fda raises concern over us unit.
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