BioSpectrum (India) - - COVER STORY -

W ith over 1500 sci­en­tists and 24 patents granted, the Ci­pla’s R&D fo­cus is to­wards de­vel­op­ing com­plex and in­no­va­tive prod­ucts. In the past two years, Ci­pla has stepped up R&D in­vest­ments tar­get­ing the US, with sev­eral as­sets such as gAd­vair, gProven­til and gAbrax­ane in the pipe­line. The R&D in­vest­ments for FY2018 was Rs 10.74 bil­lion cor­re­spond­ing to 7.1 per cent of rev­enue.

The com­pany plans to en­hance its API R&D and

man­u­fac­tur­ing ca­pac­i­ties in ther­a­peu­tic ar­eas such as Res­pi­ra­tory and On­col­ogy and con­duct back­ward in­te­gra­tion for man­u­fac­tur­ing of Key Start­ing Ma­te­ri­als (KSMs) and crit­i­cal API in­ter­me­di­ates to gain a spot at the fore­front.

The R&D in­vest­ment on Res­pi­ra­tory is slated to in­crease from 12 per cent of the to­tal R&D in­vest­ments of the com­pany in FY18 to above 30 per cent for the next year.

Key High­lights – FY2018 11 prod­ucts launched in the US; these in­clude prod­ucts such as Budes­onide Re­spules, Decitabine In­jec­tion and com­plex prod­ucts like Seve­la­mar Launched Min­is­pacer, Mul­ti­haler 60 and Syn­chro­breathe Res­pi­ra­tory de­vices in In­dia along with 19 other prod­ucts Ima­tinib 400 mg Tablets and Nifedip­ine XR tablets 30, 60 mg launched in SA

16 prod­ucts in­tro­duced in Eu­rope, which in­clude 10 res­pi­ra­tory prod­ucts

22 prod­ucts launched in in­ter­na­tional mar­kets, which in­clude 14 res­pi­ra­tory prod­ucts 7 prod­ucts were launched un­der the Ci­pla Global Ac­cess (CGA) pro­gramme

24 US ANDAs filed, in­clud­ing 7 NCE-1s

5 dossiers sub­mit­ted to DCGI, In­dia

First prod­uct filed in Brazil (Ima­tinib tablets)

First CTA filed for China (FPSM)

16 dossiers sub­mit­ted for SAGA (10 South Africa + 6 CGA)

3 prod­ucts filed in Eu­rope

4 prod­ucts filed in Aus­tralia

4 pre-IND sub­mis­sions to USFDA

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