drugset / Press release

WOCKHARDT RECEIVES TENTATIVE US FDA APPROVAL FOR GENERIC VERSION OF ANTI – PSYCHOTIC DRUG GECDON®

2012-08-22 · Wockhardt · original wockhardt.com ↗

Visit  us  at:  www.wockhardt.com   Wockhardt Limited | Wockhardt USA LLC | | 20 Waterview Boulevard | | 3rd Floor, Parsippany | | NJ 08827-1229 USA | | Tel.: +1973-2574960 | | www.wockhardt.com |   Wockhardt  receives  tentative  US  FDA  approval  for  generic  version   of  anti-­‐psychotic  drug  Geodon®     Parsippany,  New  Jersey,  Aug  22,  2012             Mumbai,  Aug  22,  2012     Pharmaceutical  and  biotechnology  major  Wockhardt  has  received  tentative  US  FDA  approval  for  marketing   a  generic  version  of  20mg,  40mg,  60mg  &  80mg  capsules  containing  Ziprasidone  hydrochloride,  which  is   used  in  the  treatment  of  bipolar  disorders  and  schizophrenia.  Ziprasidone  capsule  is  the  generic  name  for   the  brand  Geodon®,  marketed  in  the  US  by  Pfizer.  Wockhardt  will  launch  the  product  on  Sept  02,  2012.     According  to  IMS  Health,  the  total  market  for  this  product  in  the  US  is  about  $1.3  billion.     “This  is  the  fifth  US  FDA  approval  for  Wockhardt  in  the  past  8  days,”  said  Dr.  Habil  Khorakiwala,  Wockhardt   Founder  Chairman  &  Group  CEO.  “Wockhardt’s  R&D  has  ensured  a  steady  stream  of  new  products,  which   has  translated  into  a  varied  product  offering  in  the  US  markets,”  he  further  added.         In  the  US  generic  pharmaceutical  market,  Wockhardt  has  been  consistently  growing  market  shares  for  all   its  products.  In  many  instances,  Wockhardt,  by  virtue  of  being  amongst  the  few  players  to  market   technically  challenging  products  has  reaped  the  advantage  of  being  an  early  entrant.       Wockhardt  will  be  manufacturing  the  Ziprasidone  HCl  API  in  its  facility  at  Ankleshwar,  India  and  the   capsules  of  Ziprasidone  at  its  facility  in  Aurangabad,  India.  The  technology  for  the  API  and  the  capsules   were  developed  in-­‐house.     About  Wockhardt:     Wockhardt  is  a  high-­‐technology  intensive  global  pharmaceutical  and  biotechnology  company  with  multi-­‐ disciplinary  and  innovative  R&D  programmes.  It  has  3  research  centres  globally  and  manufacturing   facilities  across  India,  USA,  UK  and  Ireland.  Wockhardt  has  a  significant  presence  in  USA,  Europe  and  India,   with  75%  of  its  global  revenues  coming  from  international  businesses.  With  a  large  pool  of  Patents  and   Intellectual  Property  knowhow,  Wockhardt  is  home  to  578  scientists,  of  whom  80  are  doctorates.  In  all,   Wockhardt  has  164  Patents  granted  worldwide.  In  biotechnology  research,  it  has  built  a  competent   ‘Concept  to  Market’  capabilities  in  all  facets  of  development  and  manufacture  of  recombinant   biopharmaceuticals.  Wockhardt  boasts  of  a  multi-­‐ethnic  workforce  of  more  than  7,900  people  from  21   different  nationalities.      Geodon®  is  a  registered  trademark  of  Pfizer  Inc..

The release as fetched from its publisher. wockhardt.com ↗