BioSpectrum (India) - - COVER STORY -

Spread across 9 R&D sites in 6 coun­tries, with over 1,700 sci­en­tists and more than 3,000 patents filed glob­ally, Lupin is well po­si­tioned to cater to the unique re­quire­ments of dis­tinct mar­kets. The com­pany’s fo­cus has been to di­rect R&D spends into ar­eas that re­flect the op­por­tu­ni­ties pre­sented by the mar­kets. The out­lay of in­vest­ments in R&D of Rs 18.5 bil­lion which ac­counts for 11.9 per cent of net sales dur­ing FY2018, is a growth driver to fuel the com­pany’s fu­ture. The Com­pany has four R&D Cen­tres namely Re­search Park, Biotech Cen­tre and BioRe­search Cen­tre at Pune and one at Au­rangabad.

Key High­lights – FY2018 Filed 36 US ANDAs, re­ceived 24 ap­provals.

Filed 20 generic prod­ucts in EMEA re­gion (Eu­rope, Mid­dle East and Africa), APAC re­gion (Ja­pan & Aus­tralia), Canada and Latin Amer­ica (Brazil & Mex­ico) and re­ceived 22 ap­provals; launched 16 new prod­ucts in these mar­kets.

Sub­mit­ted 6 US DMFs (Drug Mas­ter Files), 2 Euro­pean DMFs, 3 Ja­pan DMFs.

Com­pleted Phase III Global Clin­i­cal Trial of the flag­ship project Etan­er­cept

Filed the Com­mon Tech­ni­cal Doc­u­ment (CTD) and Ap­pli­ca­tion for Mar­ket­ing Au­tho­riza­tion with the Ja­panese reg­u­la­tory au­thor­ity (PMDA),

Re­ceived ap­proval for its Biotech’s first In­ves­ti­ga­tional New Drug (IND) in the US for its late phase on­col­ogy prod­ucts.

Biotech divi­sion filed 3 new patents in In­dia and

3 Patent Co­op­er­a­tion Treaty (PCT) ap­pli­ca­tions. In ad­di­tion, 4 patent grants se­cured, 1 in the US and 3 in South Africa. Novel Drug Dis­cov­ery & De­vel­op­ment (NDDD) team has fo­cused on de­vel­op­ing a pipe­line of highly dif­fer­en­ti­ated and in­no­va­tive new chem­i­cal en­ti­ties in the ther­a­peu­tic ar­eas of On­col­ogy, Im­munol­ogy and Metabolic dis­or­ders.

Suc­cess­fully se­cured 63 patents, in­clud­ing 34 Novel Drug Dis­cov­ery & De­vel­op­ment (NDDD) patents. Lupin Biore­search Cen­tre (LBC) made a rapid progress in new ar­eas of phar­ma­ceu­ti­cal in­no­va­tion.

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