wockhardt
wockhardt stock price, share price, live bse / nse, wockhardt bids offers. buy / sell wockhardt news & tips and latest announcements - ndtv
–wockhardt receives us fda approval for antibacterial levofloxacin –wockhardt launches prostate drug flomax in the united states on day–1. –wockhardt receives us fda approval for the generic version of toprol xl, a cardiac drug .
–wockhardt launches generic version of anti–­ulcer drug prevacid. –wockhardt receives us fda approval for generic version of parkinsonism drug requip xl. –wockhardt receives tentative us fda approval for generic version of anti–psychotic drug geodon. –wockhardt receives us fda approval for generic version of parkinson? s drug comtan .
2011 –wockhardt launches generic version of protonix tablets in the us. –wockhardt receives us fda approval for generic version of effexor xr capsules. –wockhardt launches three new products in three weeks, in the united states. –wockhardt receives tentative us fda approval for generic version of patanol® ophthalmic solution .
wockhardt' s pinewood is the no. 1 branded generics company in ireland .
wockhardt reports growing q4 loss as fda issues skewer its u. s. sales
wockhardt is today amongst the top three indian pharmaceutical companies in profits and profitability .
wockhardt has received an untitled letter for a sterile injectables plant in india that wockhardt is trying to get approved by the fda to sell into the u. s .
wockhardt q3fy17 net sales at rs. 995 crore, ebitda at rs. 18 crore
the company history page lists out the major events in chronological order for wockhardt ltd .
wockhardt’s csr (corporate social responsibility) arm under wockhardt foundation has touched in a short period of time, 3 million lives through its various medical and social programmes and initiatives .
view detailed wockhardt share / stock price today. also key pivot points for daily support and resistance levels, along with the price - to - moving average action for wockhardt .
for further information about wockhardt' s full shared mission and vision, please click here .
wockhardt hospitals is associated with partners harvard medical international, an international arm of harvard medical school, usa .
the award is accompanied with a certificate allowing wockhardt to use the trademark 'best enterprise’ for marketing purposes .
india - based drugmaker wockhardt was the subject of an fda warning letter noting that seven wockhardt facilities are considered out of compliance with current good manufacturing practices .
these repeated failures at multiple sites demonstrate your company' s inadequate oversight and control over the manufacture of drugs ,
the fda wrote; wockhardt said it is addressing the issues .
wockhardt is a business in transition. new and innovative business models are in motion to make the most of emerging opportunities. a new drive for growth today permeates every mind - set, process and techno - innovation within wockhardt .
wockhardt’s csr arm under wockhardt foundation has touched in a short period of time, 3 million lives through its various medical and social programmes and initiatives. the foundation is a movement of human values, social awareness and social development .
wockhardt newspaper advertisements confirming completion of dispatch of notice of postal ballot and postal ballot form to its shar ...
india’s wockhardt has received an fda warning letter for a plant in the u. s. , making an even half - dozen warning letters for seven wockhardt plants, three of which have been banned from shipping to the u. s .
wockhardt has set up wockhardt biotech park a biopharmaceuticals manufacturing complex located at aurangabad, india. this complex comprises six manufacturing facilities developed as per usfda and emea standards. it has capacity to serve 10–15% of global demand for major biopharmaceuticals .
his signature style is much evident in the management processes at wockhardt i. e. open culture, participative management practices, innovations, continuous improvement, speedy response, empowerment and enjoying one’s job - are all hallmarks of wockhardt' s culture .
wockhardt has vast international expertise in the manufacture of pharmaceuticals and biopharmaceutical formulations as well as active pharmaceutical ingredients (api) .
this is the latest in a series of failures by wockhardt to meet the standards of not just fda but other regulators .
at wockhardt, we are looking at new ways of thinking, new ways of working and new ways to touch people’s lives .
wockhardt uk is one of the largest generic pharmaceutical companies in the uk and we pride ourselves on our long established heritage. over the years we have been known as weddel, cp pharmaceuticals and finally wockhardt in 2003, becoming wockhardt uk in 2004. since the acquisition of cp pharmaceuticals, annual uk turnover continues to grow and we now have a uk workforce of over 350 employees .
india’s wockhardt saw its losses widen last year as its burgeoning regulatory issues with the fda continue to chainsaw away at its finances .
wockhardt has also received the prestigious worldstar award in the field of packaging, this being the highest recognition in the world of packaging .
wockhardt reported a widened q4 loss, takeda penned a t - cell platform deal, and the fda approved mitsubishi’s als drug radicava .
wockhardt has been a' business superbrand' for two consecutive years - the only pharmaceutical & healthcare company in india to get this rare distinction .
seen here (l - r) wil goodheer, president of the international club of rector, dr. murtaza khorakiwala, managing director, wockhardt
wockhardt employees also had unofficial notebooks with records of sample preparation for oos investigations, route - of - synthesis experiments and scale - up data .
a keen disciple of ‘change management’, dr. habil khorakiwala has single - mindedly steered wockhardt in becoming the first true healthcare group from india. his visionary and astute leadership resulted in wockhardt emerging as a leading pharmaceutical and biotech conglomerate, driven by research and strategic thinking on a global scale .
according to wockhardt’s md, dr. murtaza khorakiwala, strategic partnerships are a less capital - intensive way of moving into new territories or acquiring new capabilities. by finding partners with complementary skills, wockhardt endeavours to find smarter ways to grow and in turn create significant value for all its stakeholders .
wockhardt has embarked on a new and exciting phase of its growth journey. as a global healthcare company, wockhardt has proved its technical excellence by developing patented modified release formulations and other complex and challenging medical technologies. we are committed to the pursuit of excellence in business and in society .
it' s strike three for india’s wockhardt, which has had a third plant in its home country banned from exporting to the u. s .
wockhardt’s core business is innovation. it uses science and technology to develop medicines and other products that improve the quality of millions people’s lives through better health .
the fda on friday added wockhardt’s bulk manufacturing plant in ankleshwar, india, to its import alert list, joining plants in waluj and chikalthana that the fda banned in 2013. the alert does not say why the plant' s products were banned but wockhardt has a history of manufacturing shortcomings at other plants .
you have talked about divestment of stake in wockhardt hospitals, sale of non - core businesses and restructuring of subsidiaries. isn' t time running out ?
the losses were also due to wockhardt' s long - term hedging instruments that were bought to reduce the interest costs for the company' s loans .
wockhardt is a true indian multi - national company with a multi - ethnic workforce of 8600 wockhardt associates from 21 different nationalities globally. it has 3 research centres and 12 manufacturing plants, with businesses ranging from the manufacture and marketing of pharmaceutical and bio - pharmaceutical formulations, active pharmaceutical ingredients (apis) and vaccines .
wockhardt combined voting results of postal ballot (remote e - voting and postal ballot forms) pursuant to regulation 44 (3) of the s ...
india’s wockhardt, which now has a record seven fda warning letters for its plants on three continents, appears to be reaching a breaking point with the agency .
the minority stake sale in wockhardt hospitals and restructuring of subsidiaries or other assets will act as a back - up or as an insurance plan for our working capital requirements and the proposed cdr plans. we are talking to multiple partners for wockhardt hospitals for selling a stake and will conclude the deal within a few weeks .
wockhardt was four times in a row, awarded the prestigious patent award by the government of india, for the ‘maximum number of patent filings and grants from india’ .
wockhardt was ranked 76th amongst the world’s top 100 pharmaceutical companies and only the 4th indian pharmaceutical company in this elite 100 group (scrip 100, 2011 edition) .
due to global bovine insulin raw material unavailability, wockhardt has no choice but to discontinue the hypurin® bovine insulin range. unfortunately, despite our best efforts in trying to find an alternative supply of bovine insulin raw material, none has been found. wockhardt regrets any inconvenience this may cause but unfortunately the circumstances are beyond our control .
wockhardt combined voting results of postal ballot (e - voting and postal ballot forms) pursuant to regulation 44 (3) of the sebi (li ...
if you look at wockhardt as a pharmaceutical company, it was one of the best performing companies in the first nine months of 2008, excluding foreign currency losses .
efforts by wockhardt to fix violations at drug plant in wrexham, wales are inadequate according to the us fda which detailed its concerns in a warning letter this week .
wockhardt works with partners to in - license products in india and out - license products into other regions by capitalising on these collaborative strengths to capture and penetrate new markets .
the agency is concerned about wockhardt’s responses to these matters. among other things, although wockhardt was made aware of a major product defect / problem during fda’s march 22, 2013 inspection at a wockhardt facility located in biotech park, midc area waluj, aurangabad, india, you did not take appropriate actions to resolve the “trial” sample injection problem discussed above at the biotech park facility or elsewhere within wockhardt’s organization. senior management is responsible for ensuring the quality, safety, and integrity of your firm’s products. implementing adequate controls to prevent the manipulation of laboratory data, assuring timely investigation and resolution of product defects, and preventing distribution of defective products are all fundamental aspects of these responsibilities .
wockhardt? s core business is innovation. it uses science and technology to develop medicines and other products that improve the quality of millions people? s lives through better health .
considering the strong technical position of wockhardt on charts, i' d advise investors to buy its stock with a target of rs 760 and a stop loss of rs 714 .
wockhardt is a true indian pharmaceutical multinational with full - fledged operations in several countries, including us, uk, ireland and france. in an exclusive interaction with the dollar business, dr. murtaza khorakiwala, managing director of wockhardt group, talks about the company’s innovative business models that are in motion to make the most of emerging opportunities across the globe .
wockhardt is the 4th company in the world to have developed recombinant insulin, wosulin - from concept to market stage. it also developed a patented delivery device ‘pen’ for wosulin injections .
wockhardt ltd. , incorporated in the year 1999, is a mid cap company (having a market cap of rs 7000. 66 crore) operating in pharmaceuticals and health care sector .
wockhardt is the 4th company in the world to have developed recombinant insulin, wosulin – from concept to market stage. it also developed a patented delivery device? pen? for wosulin injections .
dr. habil khorakiwala strongly advocates that the only way towards fast growth is to be' customer focussed'. this customer - centric approach has filtered down to every decision and action in wockhardt .
wockhardt incorporated in 1999, is engaged the pharmaceutical and biotechnology segments. the company? s 14 manufacturing plants are located in india, uk, ireland, us, and are compli ...
the state–of–the–art biotech plant in aurangabad has six dedicated manufacturing facilities for biopharmaceutical bulk as well as recombinant formulations. the wockhardt biotech park has created its own benchmark in manufacturing recombinant products with world–class technology .
wockhardt is in the forefront of intellectual property creation with 1, 733 patents filed till date, of which 228 patents have been granted. our capability and commitment in pursuing intellectual property has been recognised by the government of india for four years in a row, with an award for the maximum number of ‘patent filings and grants from india’. wockhardt is determined to create benchmarks for a promising future .
wockhardt? s subsidiaries are located in the us, uk, ireland and france. the company has market presence in formulations, bio–pharmaceuticals, nutrition products, vaccines and active pharmaceutical ingredients (apis) .
finding wockhardt a promising stock with surety of its delivering solid returns ahead, i' d advise investors to buy its stock with an intraday target of rs 760 and a stop loss of rs 714 .
wockhardt ltd. ’s regulatory troubles continued apace this week, with the release of yet another warning letter from the fda, the second such letter this calendar year. the india - based ...
wockhardt is in the forefront of intellectual property creation with 1, 411 patents filed till date, of which 145 patents have been granted. our capability and commitment in pursuing intellectual property has been recognized by the government of india for three years in a row, with an award for the maximum number of? patent filings and grants from india? . wockhardt is determined to create benchmarks for a promising future .
the company holds strong position in leading markets such as europe and united states, which contributes 65% to wockhardt' s revenue. the company has two subsidiaries negma lerads, france and morton grove pharmaceuticals, usa .
wockhardt has proved its technical excellence by developing patented modified release formulations and recombinant biotechnology products. it has a multi–disciplinary r & d programme with more than 550 scientists, including over 100 doctorates, in the areas of :
the food and drug administration (fda) said wockhardt’s response to the inspection – which it received late last year - was ‘inadequate’ and advised it to hire a consultant to help it bring the facility up to code .
all of wockhardt' s u. s. targeted manufacturing facilities are under some kind of fda oversight, but the indian generics maker got a new product approved for the u. s. market by using a contractor .
the beleaguered indian drug manufacturer wockhardt is in trouble again with the us food and drug administration (fda), this time for destroying current good manufacturing practice (cgmp) documents, among a list of other major violations .
wockhardt has proved its technical excellence by developing patented modified release formulations and recombinant biotechnology products. it has a multi - disciplinary r & d programme with more than 607 scientists, including over 80 doctorates, in the areas of :
h abil khorakiwala, executive chairman of wockhardt, says he has seen many ups and downs in his business since he inherited drug trading firm worli chemicals many decades ago and transformed it into india' s sixth largest drug company .
sitting in his plush ninth floor office at the wockhardt headquarters at the bandra kurla complex, khorakiwala, 66, talks to shyamal majumdar and p b jayakumar on the reasons for seeking corporate debt restructuring, and the road ahead .
wockhardt aspires to create a healthier world. its strategic vision of ‘more & more with less & less’ has transformed into new ways of thinking, a new journey for growth, medical breakthroughs for patients and continuing value for all stakeholders .
wockhardt was hit with a seventh fda warning letter, china' s fda chief pledged to speed up approvals of foreign drugs, and an indian court ruled on patent cases concerning copycats of herceptin and two on - patent bayer blockbusters .
wockhardt chairman habil khorakiwala last year told investors the company hoped to get those two plants again approved for u. s. exports in 2016. the remarks came a day after the indian drugmaker reported that sales in the u. s. last fiscal year were off by 50% . in its latest annual report, wockhardt reported that total revenues for the company were off about 6% to $ 674 million but didn’t break out its u. s. sales .
new delhi: the us food and drug administration (us fda) has 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 .
the state - of - the - art biotech plant in aurangabad has six dedicated manufacturing facilities for biopharmaceutical bulk as well as recombinant formulations. the wockhardt biotech park has created its own benchmark in manufacturing recombinant products with world - class technology .
wockhardt uk are pleased to confirm to concerned patients that migril® tablets are fully available with good stock levels to ensure committed supply. patients should visit their healthcare professional to discuss treatment options. pharmacists can order migril® tablets from the usual wholesalers .
in the annual report, wockhardt noted that the fda had observations after inspection of four of its plants, including the ankleshwar facility, as well as its plants in chikalthana and waluj, where it said remediation efforts were still under way .
uly 22 - 31, 2013 simultaneous inspections of your pharmaceutical manufacturing facilities, wockhardt limited (fei 3002808503) located at l - 1, m. i. d. c. area, chikalthana, aurangabad, maharashtra, india, and wockhardt limited (fei 3004540156) located at b - 15 / 2, m. i. d. c. area, waluj, aurangabad, maharashtra, india, investigators from the u. s. food and drug administration (fda) identifi
last month, the us drug regulator found seven violations of manufacturing standards at sun pharmaceutical industries ltd’s formulations plant in mohali, punjab. also, the us food and drug administration had issued a warning to wockhardt for violating current good manufacturing practice norms .
in the pharma space, wockhardt is a promising stock with surety of its delivering solid returns ahead, therefore needs to be bought around levels rs 725 - 720 wherein keeping a short - term target at rs 775 and a stop loss below rs 702 .
wockhardt has 3 research centres globally with over 607 scientists of which over 80 are doctorates. its multi - disciplinary research activities encompass pharmaceutical formulations, biopharmaceutical bulk and formulations, novel drug delivery system, new drug discovery programme and process engineering for active pharmaceutical ingredients .
wockhardt is a global pharmaceutical and biotechnology organisation, providing affordable, high - quality medicines for a healthier world. it is india’s leading research - based global healthcare enterprise with relevance in the fields of pharmaceuticals, biotechnology and a chain of advanced super speciality hospitals .
the u. s. food and drug administration (fda) inspected your drug manufacturing facility, wockhardt limited, plot no. 138 g. i. d. c. estate district bharuch, ankleshwar, gujarat, from december 7 to 15, 2015 .
in a warning letter issued by the fda, products from morton grove pharmaceuticals, a wockhardt limited subsidiary, will still be available in the market but new approvals will be withheld until regulatory compliance issues are addressed. morton grove manufactures topical and oral liquid drugs .
tdb: could you give us some insights into the journey of wockhardt group? dr. murtaza khorakiwala (mk): wockhardt ranks amongst india’s leading pharma and biotech companies with a global footprint and a strong r & d focus. it traces its roots back to the 1960s when the khorakiwala family bought a pharma company that primarily manufactured medicines for common cold and cough. till 1992, the company centred its operations towards becoming a major player in the indian pharma industry. thereafter, it concentrated on becoming a global drug maker .
in the letter to wockhardt chairman and group ceo habil khorakiwala, the us fda said inspectors during inspection from 7 to 15 december 2015, found “significant violations” of current good manufacturing practice (cgmp) regulations for finished pharmaceuticals as well as for active pharmaceutical ingredients (api) .
wockhardt' s facility in maharashtra, india, has received a good manufacturing practice certificate from the uk' s medicines and healthcare products regulatory agency after it passed inspection requirements. the generics and antibiotics maker has previously been banned by uk and us regulators due to gmp violations .
tdb: what role have acquisitions played in wockhardt’s growth? mk: acquisitions have helped wockhardt continuously strengthen its presence in the global market. in 1998, we acquired merind, a former affiliate of merck sharp & dohme of us. this enabled the company to penetrate into new therapeutic areas like corticosteroids, psychiatry and neurology. the same year, wockhardt also acquired uk - based wallis laboratory. later in 2003, it took over cp pharmaceuticals, another uk - based company, thereby gaining access to a large customer base of hospitals under the national health service (nhs). largely due to these highly successful acquisitions, today, it is the largest indian pharmaceutical company in uk. expansion through acquisitions continued in 2004 when we acquired the brands, businesses and marketing infrastructure of esparma gmbh of germany, followed by the purchase of us - based morton grove and france - based negma laboratories. today wockhardt’s manufacturing facilities, with capabilities for both finished dosage formulations and active pharmaceutical ingredients (apis), are spread across india, us and uk. the company has subsidiaries in us, uk and mexico, and marketing offices in africa, russia, central and southeast asia. such has been the diversification that india, which in 2000 contributed to about 78% of wockhardt’s business, now contributes just about 32% to the total revenue. the rest 68% comes from overseas markets .
tdb: today antimicrobial resistance (amr) is being considered as a major problem globally. however, wockhardt is amongst the top pharma giants that have vowed to eradicate it. can you elaborate a bit more on this? mk: today, globally, amr is responsible for more than 0. 7 million deaths annually and the number is slated to increase to 10 million by 2050. due to amr, the additional healthcare cost per year is approximately $ 4 billion, globally. moreover, it has resulted in a collateral damage – the ability of the global healthcare system to manage various surgeries, organ transplants, etc. , has been compromised. wockhardt’s drug discovery programme focuses on finding novel solutions to this growing threat and has achieved significant successes in fulfiling these needs. with five new drugs accorded qualified infectious disease product (qidp) status, wockhardt aspires for global leadership in antibiotics .
wockhardt' s 12 manufacturing plants are located in india, uk, ireland, us, and are compliant to international regulatory standards including us fda and uk mhra. these manufacturing plants are multi - technology and can manufacture all the dosage forms including sterile products as well as products with lyophilised dosage forms .
dr. habil khorakiwala is the founder chairman & group ceo of wockhardt limited, a company he founded in the early 1960s. he holds a masters in pharmaceutical science from purdue university, and has participated in an advanced management programme at harvard business school, usa. he is also the recipient of an honorary doctorate from purdue university, usa .
headquatered in mumbai, india, wockhardt has full - fledged operations in the usa, uk, ireland and france. it also has its marketing presence in emerging markets of russia, brazil, mexico, vietnam, philippines, nigeria, kenya, ghana, tanzania, uganda, nepal, myanmar, sri lanka, mauritius, lebanon and kuwait .
wockhardt ltd is a global pharmaceutical and biotechnology organization providing affordable high - quality medicines for a healthier world. the company is india' s leading research - based global healthcare enterprise with relevance in the fields of pharmaceuticals biotechnology and a chain of advanced super speciality hospitals. the company has twelve manufacturing locations and there are five locati... > more
the fourth plant was a new sterile injectables facility in shendra that wockhardt saw as its best shot at restoring a u. s. business devastated by the fda product bans. but the company earlier this year said the fda found issues during an inspection to determine if it was ready for u. s. approval. - find the import alert here
finally, we note again that the cgmp violations listed in this letter include similar violations to those cited in the wl 320 - 13 - 21, issued on july 18, 2013. it is apparent that wockhardt is not implementing global and sustainable corrective actions. it is essential that your firm implement a robust quality system. we remind you that you are responsible for ensuring that your firm’s drug manufacturing operations comply with applicable requirements and produce acceptable quality drugs. fda strongly recommends that wockhardt’s executive management immediately undertake a comprehensive and global assessment of your manufacturing operations to ensure that your systems and processes, and ultimately, the drug products you manufacture, conform to fda requirements for safety, efficacy, and quality .
in addition, our investigator discovered that some of the “trial” injection data was not kept on the hplc hard drives because your firm deleted it. your firm’s management confirmed that the files were deleted as part of an internal audit conducted as a result of the march 2013 fda inspection at your nearby wockhardt limited facility located in waluj (fei: 3005289335) .
the agency followed the earlier bans up with a warning letter that criticized the drugmaker for hiding failed testing results and manipulating tests to make it appear that drug batches had met fda standards when they hadn’t. the fda said wockhardt employees at the waluj plant had tried to destroy records and lied to inspectors about having giving them access to all drug manufacturing areas .
wockhardt incorporated in 1999, is engaged the pharmaceutical and biotechnology segments. the company? s 14 manufacturing plants are located in india, uk, ireland, us, and are compliant to international regulatory standards including us fda and uk mhra. these manufacturing plants are multi–technology and can manufacture all the dosage forms including sterile products as well as products with lyophilised dosage forms .
we are particularly concerned about your inability to implement a robust and sustainable quality system. the findings from our current inspections include repeat citations from fda’s inspection of the wockhardt waluj, aurangabad, india facility conducted in march 2013. these repeated observations and citations indicate that your quality unit is not exercising its responsibilities and may not have the appropriate authority or ability to carry out its responsibilities .
law360, new york (march 7, 2017, 8: 14 pm est) - - the u. s. food and drug administration once again scolded drugmaker wockhardt for testing and record - keeping issues at a subsidary' s plant, an issue that’s caused trouble for the drugmaker in the past, and chastised a washington smoked salmon maker for listeria found in its facility .
wockhardt ltd. key products / revenue segments include pharmaceuticals which contributed rs 2146. 00 crore to sales value (93. 40% of total sales), licence fees which contributed rs 114. 41 crore to sales value (4. 97% of total sales), sale of services which contributed rs 37. 11 crore to sales value (1. 61% of total sales) for the year ending 31 - mar - 2017 .
wockhardt’s founder chairman and group ceo, dr. habil khorakiwala says, “a decade ago, i saw a changing world that i believed would present us with large - scale future opportunities in the field of pharmaceuticals and biotechnology. we steered our business model to leverage our research capabilities in providing innovative solutions and by constantly upgrading our world - class manufacturing facilities. we ventured outside india systematically and positioned ourselves mainly in the european and the us markets, which currently generates over 76% of our revenues. ”
tdb: medical tourism is gaining momentum in india. what can be done to make india more attractive to patients from across the world? mk: india is not only price - competitive compared to other south - east asian countries but is also high on the skill index. this has resulted in a large influx of international patients, over the last quarter of a century. currently, a reasonable amount of business is coming to metros such as bengaluru, hyderabad, chennai, delhi and mumbai, largely from the third world countries. it is estimated that roughly 5% of the business of high - end tertiary care hospitals in metros and tier i cities comes from global patients. at wockhardt hospitals, business from international patients is rapidly rising at a pace of 60 - 70% every year. at our hospitals in south and north mumbai, international patients constitute a substantial portion of our business. wockhardt has been able to reach out to various under - served geographies and is also privileged to leverage the wockhardt brand and network. our clinical acumen and credibility makes us stand out from the crowd. the two major markets of medical value travel are the underdeveloped interiors of the african subcontinent and the middle east. this constitutes about half of the medical value travellers arriving in india. india must look at it as an activity of creating dollar tourism and follow programmes created by countries such as thailand. the issuance and of medical visas should be increased considerably and specific facilities should be created with help from the private sector to generate high - value medical tourism .
tdb: besides india and uk, which other markets are of importance to you and where are you looking to expand? mk: when it comes to overseas markets, us contributes significantly, after uk. at the same time, emerging markets in asia, africa, cis and latin america – where wockhardt has a portfolio of more than 50 products with a strong network of more than 65 regional partners – are important as well. we are currently looking to expand into the fast - growing and strategically important emerging markets .
until all corrections have been completed and fda has confirmed corrections of the violations and your firm’s compliance with cgmp, fda may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer. in addition, your failure to correct these violations may result in fda refusing admission of articles manufactured at wockhardt limited (fei 3002808503) located at l - 1, m. i. d. c. area, chikalthana, aurangabad, maharashtra, india and wockhardt limited (fei 3004540156) located in b - 15 / 2, m. i. d. c. area, waluj, aurangabad maharashtra, india into the united states under section 801 (a) (3) of the act, 21 u. s. c. 381 (a) (3). the articles may be subject to refusal of admission pursuant to section 801 (a) (3) of the act, 21 u. s. c. 381 (a) (3), in that the methods and controls used in their manufacture do not appear to conform to cgmp within the meaning of section 501 (a) (2) (b) of the act, 21 u. s. c. 351 (a) (2) (b) .
none of the facilities inspected since june 2014 (33 months ago) and subsequently receiving warning letters have had resolution. since gdufa, the nine resolutions done took an average of ~ 500 days post warning letter issuance. cadila healthcare’s moraiya unit (426 days) looks poised to be resolved soon post its recent re‐audit that had no fda observations. while data suggests that sun pharmas’ halol unit (432 days) and dr reddy’s (474 days) are closer to resolution timeframe, the concern is that the warning letters are not easy to resolve. other facilities of listed companies under import alert due to inspections post gdufa include wockhardt’s 4 units, ipca’s units and sun pharma’s karkhadi unit, the edelweiss report added .
tdb: where do these five qidp designated drugs currently stand in the drug development cycle? mk: the five qidp - designated novel antibacterial drugs (wck 771, wck 2349, wck 4873, wck 4282 and wck 5222), are in advanced stages of clinical development. they belong to four different classes of antibiotics. each of these new antibiotics has a distinct mechanism of action, making them active against multidrug - resistant pathogens responsible for serious infections. wockhardt’s new antibiotics would be useful in the treatment of bloodstream infections, pneumonia, surgical wound infections, community respiratory infections and pneumonia caused due to ventilators. all these products have the potential to significantly reduce the mortality and morbidity attributed to life - threatening infections in both hospital and community settings .
failure to correct these violations and deviations may also result in fda continuing to refuse admission of articles manufactured at wockhardt limited, plot no. 138 g. i. d. c. estate district bharuch, ankleshwar, gujarat, into the united states under section 801 (a) (3) of the fd & c act, 21 u. s. c. 381 (a) (3). under the same authority, articles may be subject to refusal of admission, in that the methods and controls used in their manufacture do not appear to conform to cgmp within the meaning of section 501 (a) (2) (b) of the fd & c act, 21 u. s. c. 351 (a) (2) (b) .
until all corrections have been completed and fda has confirmed corrections of the violations and your firm’s compliance with cgmp, fda may withhold approval of any new applications or supplements listing your firm as a drug product manufacturer. 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 h - 14 / 2, m. i. d. c. area waluj, aurangabad, india into the united states under section 801 (a) (3) of the act, 21 u. s. c. 381 (a) (3). the articles may be subject to refusal of admission pursuant to section 801 (a) (3) of the act, 21 u. s. c. 381 (a) (3), in that the methods and controls used in their manufacture do not appear to conform to cgmp within the meaning of section 501 (a) (2) (b) of the act, 21 u. s. c. 351 (a) (2) (b) .
tdb: what opportunities and challenges do you foresee for indian pharma companies in foreign markets? mk: india is likely to gain its fair share of global opportunities that are currently emerging around biosimilars. indian biotech companies are building capabilities in development and manufacturing of biosimilars. the development of biosimilars is more challenging than the development of small - molecule generics due to the greater complexity of biological drugs and the complex manufacturing process. it is because of this inherent complexity that the production, approval and uptake of biosimilars follow a different trajectory than that of the existing generic drugs market. we recognised this opportunity early and went through the learning curve with high involvement and commitment. in fact, our products have been well received by clinicians as well as patients in over 25 countries around the globe. another area of opportunity for india is new drug discovery research. while it’s at a nascent stage, new drug discovery research by indian fraternity is gaining momentum on the global landscape. the indian pharma industry has reached mid - to - late - stage global clinical development in areas of diabetes, respiratory diseases, immunology and oncology. the global antibiotic scenario has deteriorated considerably due to rising resistance to existing medication, lack of new medicines and an increase in new resistant organisms. this became more complicated when most pharmaceutical majors distanced themselves from the anti - infective development research and moved towards the chronic illness space. against this backdrop, wockhardt discovery engaged itself in the pursuit of developing new antibiotics with the vision of targeting the realm of unmet medical needs. two decades of research yielded five major drugs. though very rewarding, new drug development is a lengthy, complex and expensive process, entrenched with a high degree of uncertainty .
limited located at biotech park, plot h - 14 / 2, m. i. d. c. area waluj, aurangabad, india, investigators from the u. s. food and drug administration (fda) identifi
ed significant violations of current good manufacturing practice (cgmp) regulations for finished pharmaceuticals, title 21, code of federal regulations, parts 210 and 211, and documented that your firm withheld truthful information, and delayed and limited the inspection. these violations cause your drug products to be adulterated within the meaning of section 501 (a) (2) (b) and 501 (j) of the federal food, drug, and cosmetic act (the act), 21 u. s. c. 351 (a) (2) (b) and 351 (j), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, cgmp, and in that your drug products have been manufactured, processed, packed, or held in an establishment and the owner or operator has delayed, denied, or limited an inspection, or has refused to permit entry or inspection, respectively .
we have conducted a detailed review of your firm’s response of april 9, 2013 and note that it lacks sufficient corrective actions .
1. your firm repeatedly delayed, denied, limited an inspection or refused to permit the fda inspection. examples are as follows :
on march 18, 2013, an fda investigator identified the presence of torn raw data records in the waste area and asked one of your firm’s qa officers to remove these torn raw data records for the investigator’s review. this qa officer presented the fda investigator with approximately 20 paper records, none of which included raw data entries identified in the waste area earlier during the inspection. the fda investigator asked three times if there were any more records found in the waste area, and the qa officer responded to each question ,
no, this is all of the records”. the fda investigator then re - visited the waste area and found that the raw data records had been removed and placed in a different holding bag. these records included raw data testing worksheets from anti - microbial effectiveness studies, controlled master batch records for
)
, equipment calibration records, and stability protocol records. because you provided some, but not all, of the records requested by the investigator that fda had the authority to inspect, you limited access to or copying of records for the fda inspection. because you directed fda investigators away from the requested documents, and because the fda investigator was impeded by having to locate and reassemble torn records that fda had requested and had the authority to inspect, you delayed the inspection .
on march 18, 2013, an fda investigator identified the presence of unlabeled and partially labeled vials in the laboratory glassware washing area. when the investigator asked a qc analyst to describe the contents of these vials, the qc analyst immediately began dumping the contents of the vials into the drainage sink. the qc analyst stated that the content of the vials could not be determined. because you limited the direct observation by the fda investigator and prevented any determination of the contents of the unlabeled vials, you limited the inspection .
on march 19, 2013, an fda investigator interviewed the production head regarding his knowledge of the unofficial batch record forms being used to record the results for the visual inspection of drug products. the production head stated that he had only seen this unofficial defect data for
1 to 2 batches
. the fda investigator had an earlier conversation with two manufacturing operators, who stated that the production head had directed this practice throughout the manufacturing facility and regularly requested and reviewed the unofficial bmr visual inspection results. on march 21, 2013, the production head stated that he was fully aware of the practice of using unofficial batch record copies during the course of manufacturing operations. the production head acknowledged that he had provided inaccurate information in the previous instances. by stating that the data that existed was limited to one or two batches and that no other data existed, you provided some, but not all, of the records requested by the investigator that fda had the authority to inspect. additionally, you limited access to or copying of records for the fda inspection. because you denied the existence of records that fda had requested and had the authority to inspect in order to obstruct the direct observation of the requested documents, you delayed the inspection .
aseptic filling line for all products (vials and pre - filled syringes) produced for the u. s. market. however, the fda investigators later identified
aseptic filling line for pre - filled syringes manufactured for export to the u. s. market, in use since at least september 2009. the area was operational and was an area of the inspection site that fda has authority to inspect. the fda investigator was impeded at the inspection site from properly performing the inspection in a reasonable manner. because you directed the fda investigator away from this production area, you obstructed the direct observation of the manufacturing process to an unreasonably short amount of time, and you limited the inspection. because the investigator only later discovered the existence of the area, you delayed the inspection .
# (b) (4). the investigator repeated the request no less than six times on march 20, 2013, and again multiple times on march 21, 2013. the data was provided to the fda investigator during the close - out meeting of the inspection on march 22, 2013. you failed to produce the requested records within the timeframe requested by the investigator without adequate justification. by delaying the provision of requested data and documents until the last scheduled day of the inspection without reasonable explanation, you limited the ability of the investigator to review and analyze the documents to an unreasonably short amount of time and you delayed the inspection .
2. your firm failed to prepare batch production and control records for each batch of drug product that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch (21 cfr 211. 188 (b) ) .
for example, on march 18, 2013, the fda investigators found unofficial batch records for approximately 75 batches of injectable finished drug products torn in half in a waste area. these records contain data indicating that some batches failed to meet the in - process visual inspection specifications of not more than (b) (4)% defects, while the official batch records for these batches state that these batches had met the specifications. the uncontrolled documents indicate that up to 14% of vials had defects including, but not limited to, black particles, fibers, glass particles, sealing defects, and volume variations. according to your firm’s procedures, a defect rate higher than (b) (4)% requires initiation of an investigation; however, a senior production officer at your firm stated that no investigations are performed when this occurs .
your firm’s response indicates that these issues are for products not related to the u. s. market, and that they pertain solely to the formulation (b) (4) building. additionally, you indicate that the quality unit is not involved in the use of uncontrolled records. you also indicate that your firm re - inspected the batches referenced in the fda observation. you provided an affidavit from your senior production officer stating “each and every identified defect unit during in - process visual inspection was rejected and only good units were transferred to the next stage for 100% visual inspection after filling. ”
your response is inadequate because your facility manufactures (b) (4) injection in pre - filled syringes for the u. s. market in the same formulation (b) (4) building where these torn records were observed. your response did not address why your quality unit is not performing its duty to control records used in the manufacture of your drug products. your investigation for the products listed in the form fda 483 was limited and failed to include all of the other drugs manufactured by your facility. your affidavit confirms that your firm uses unofficial visual inspection to remove the defective units from the production line without appropriate documentation and investigation .
the above examples raise serious concerns regarding the integrity, reliability and accuracy of the data generated and available at your facility. in your response to this letter, provide an independent and comprehensive evaluation of the extent of the deletion and destruction of records, a risk assessment regarding the potential impact on the quality of products, and a comprehensive corrective and preventive action plan. your submission should include a summary report of your evaluation of the data and records related to the manufacture (including testing, holding, etc .) of all drug products produced at your site. this evaluation should include a detailed investigation of other instances in which your operations and quality units failed to ensure proper testing of materials, review of laboratory results and production data. for all other instances of missing, inaccurate or unreliable tests results are found, describe these findings in your response to this letter. your investigation should assess the impact of all these incidents on the quality of the drug products manufactured and released into distribution, and explain the systemic actions that will be instituted to prevent these fundamental breaches of data integrity and management oversight in the future .
accordingly, you should include a detailed description of your plans to implement a robust quality system in your response to this letter. this remediation plan should describe the broader steps you will be taking to ensure direct corporate oversight over the quality and operations functions of this facility. this system should ensure sustainable compliance with cgmp, including the basic capability to prevent data manipulation and destruction of records .
3. your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 cfr 211. 194 (a) ) .
for example, your firm’s laboratory records failed to include complete records of all stability testing performed. the fda investigators identified the practice of performing
trial
sample analysis for high performance liquid chromatography (hplc) analyses prior to collecting the “official” analytical data for stability testing. these “trials” were performed on multiple products, including (b) (4) tablets (b) (4) mg, (b) (4) mg / (b) (4) ml, and (b) (4) tablets. these trial runs were not recorded in the equipment use log, and sample preparation data associated with these analyses was destroyed, preventing any calculation or analysis of the resulting data. your response states that trial runs were conducted using only one of the (b) (4) hplc instruments located in the stability laboratory, which happened to be the one instrument that the fda investigators reviewed during the inspection. your response indicates that you have revised procedures and re - trained your staff .
additionally, your quality control hplc raw data files can be deleted from the hard drive using the common pc login used by all (b) (4) analysts. this deletion eliminates all records of sample injections and analyses. your response indicates that this deletion function is only available on the software used for one of (b) (4) sets of hplc instruments. you also indicated that you have changed the access control privileges such that laboratory analysts in a “user” role cannot delete or rename files.
wockhardt ltd. is a pharmaceutical and biotechnology company headquartered in mumbai , india . the company has manufacturing plants in india , uk , ireland , france and us , and subsidiaries in us , uk , ireland and france . it is a global company with more than half of its revenue coming from europe . in 2011 – 2012 its uk and usa sales alone were us$ 475 million . it has market presence in emerging markets such as russia , brazil , mexico , vietnam , philippines , nigeria , kenya , ghana , tanzania , uganda , nepal , myanmar , sri lanka , mauritius , lebanon and kuwait . the company has a market capitalisation of over ₹ 211 billion ( us$ 3.3 billion ) and an annual turnover of ₹ 36 billion ( us$ 560 million ) . it produces formulations , biopharmaceuticals , nutrition products , vaccines and active pharmaceutical ingredients ( apis ) . the company employs over 8,600 people globally . wockhardt hospitals is a subsidiary of the wockhardt group . 
wockhardt ltd. is a pharmaceutical and biotechnology company headquartered in mumbai, india. the company has manufacturing plants in india, uk, ireland, france and us, and subsidiaries in us, uk, ireland and france. it is a global company with more than half of its revenue coming from europe. in 2011 – 2012 its uk and usa sales alone were us$ 475 million. it has market presence in emerging markets such as russia, brazil, mexico, vietnam, philippines, nigeria, kenya, ghana, tanzania, uganda, nepal, myanmar, sri lanka, mauritius, lebanon and kuwait. the company has a market capitalisation of over ₹ 211 billion (us$ 3.3 billion) and an annual turnover of ₹ 36 billion (us$ 560 million). it produces formulations, biopharmaceuticals, nutrition products, vaccines and active pharmaceutical ingredients (apis). the company employs over 8,600 people globally. wockhardt hospitals is a subsidiary of the wockhardt group.
wockhardt ltd. is a pharmaceutical and biotechnology company headquartered in mumbai, india. the company has manufacturing plants in india, uk, ireland, france and us, and subsidiaries in us, uk, ireland and france. it is a global company with more than half of its revenue coming from europe. in 2011 – 2012 its uk and usa sales alone were us$ 475 million. it has market presence in emerging markets such as russia, brazil, mexico, vietnam, philippines, nigeria, kenya, ghana, tanzania, uganda, nepal, myanmar, sri lanka, mauritius, lebanon and kuwait. the company has a market capitalisation of over ₹ 211 billion (us$ 3.3 billion) and an annual turnover of ₹ 36 billion (us$ 560 million). it produces formulations, biopharmaceuticals, nutrition products, vaccines and active pharmaceutical ingredients (apis). the company employs over 8,600 people globally. wockhardt hospitals is a subsidiary of the wockhardt group.