Dr Reddy’s Labs

BioSpectrum (India) - - COVER STORY -

With 18 man­u­fac­tur­ing units, 4 R&D units, 2 tech­nol­ogy de­vel­op­ment cen­tres in In­dia, the R&D ex­penses for Dr Reddy’s Labs dur­ing FY2018 were Rs 18.265 bil­lion, or 12.9 per cent of rev­enue ver­sus 13.9 per cent in FY2017. Ac­cord­ing to Dr Reddy’s, the ab­so­lute and pro­por­tional de­crease in R&D spends is in line with the con­tin­ued fo­cus on cost op­ti­miza­tion, pro­duc­tiv­ity im­prove­ment, and pri­or­i­ti­za­tion of projects, which have been ex­e­cuted in a man­ner that does not im­pinge on the com­pany’s fo­cus on build­ing the pipe­line of com­plex gener­ics, biosim­i­lars, and dif­fer­en­ti­ated prod­ucts.

Key High­lights – FY2018 Fo­cus on ad­vanc­ing the de­vel­op­ment of the 2 in-li­censed as­sets- a) XP-23829 ac­quired from XenoPort, which is a clin­i­cal stage new oral en­tity that has the po­ten­tial for the treat­ment of plaque pso­ri­a­sis and may even be de­vel­oped for re­laps­ing forms of mul­ti­ple scle­ro­sis; and b) E7777, from Ei­sai, which is an anti-can­cer agent. De­vel­op­ing some in­ter­nal pipe­line prod­ucts that in­volve der­ma­to­log­i­cal and neu­ro­log­i­cal as­sets, which are in midto-late stage de­vel­op­ment.

Launched 15 new prod­ucts in North Amer­ica – the ma­jor ones be­ing Li­po­so­mal Dox­oru­bicin, Eze­tim­ibeSim­vas­tatin, Seve­lamer, Palonosetron in­jec­tion and Bi­val­rudin in­jec­tion.

Filed 19 new US ANDAs and 1 New Drug Ap­pli­ca­tion (NDA).

110 generic fil­ings pend­ing ap­proval from the USFDA, com­pris­ing 107 ANDAs and three NDAs filed un­der the 505(b)(2) route of the US Fed­eral Food, Drug and Cos­metic Act. Of the 107 ANDAs, 63 are Para IV ap­pli­ca­tions, of which 30 have ‘First to File’ sta­tus.

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