Aurobindo Pharma

BioSpectrum (India) - - COVER STORY -

Aurobindo Pharma has a team of over 19,000 pro­fes­sion­als from 31 dif­fer­ent coun­tries work­ing at its var­i­ous di­vi­sions – API man­u­fac­tur­ing, for­mu­la­tion man­u­fac­tur­ing, chem­i­cal R&D, for­mu­la­tion R&D and over­seas op­er­a­tions.

About 80 per cent of these em­ploy­ees are grad­u­ates, post­grad­u­ates and PhD hold­ers. Dur­ing FY2017-18, Aurobindo’s to­tal R&D spend stood at Rs 6.66 bil­lion, which is 4 per cent of its to­tal rev­enue. The com­pany’s R&D ef­forts have been fo­cused on strength­en­ing the prod­uct port­fo­lio. Dur­ing FY2018, Aurobindo launched 38 prod­ucts, in­clud­ing 6 in­jecta­bles in the US.

Key High­lights – FY2018 Filed 7 ANDAs in the On­col­ogy Seg­ment.

To start Phase I clin­i­cal tri­als for Be­va­cizumab – a biosim­i­lar to Avastin in FY2018-19.

Started an­i­mal toxic stud­ies on an oph­thalmic prod­uct which will be ready for Phase III tri­als in FY2019-20.

Filed 4 DMFs with US reg­u­la­tory au­thor­i­ties and plan­ning to file an ad­di­tional 3 DMFs in FY2018-19 in pep­tides seg­ment.

Ap­proval re­ceived for Er­tapenem in­jec­tion and is in the process of launch­ing in US and Eu­rope. Pro­duced ex­hibit batches for 2 prod­ucts of Der­ma­tol­ogy Topi­cals and plan­ning to ex­e­cute ex­hibit batches for an­other 17 prod­ucts in FY201819.

Filed first ANDA for Der­ma­tol­ogy Topi­cals in the first quar­ter of FY2018-19; and plan­ning to file an­other 5 ANDAs by the end of this fis­cal.

Started clin­i­cal stud­ies for der­ma­tol­ogy trans­der­mal prod­ucts in June 2018 and the first ANDA for patches will be filed in Novem­ber 2019. To file 2 ANDAs of res­pi­ra­tory prod­ucts in FY201819 and the re­main­ing will be filed in FY2019-20. Re­ceived ap­proval to con­duct Phase I clin­i­cal tri­als for pneu­mo­coc­cal con­ju­gate vac­cine (PCV) from the Drug Con­troller Gen­eral of In­dia (DCGI) in April 2018; ini­ti­ated the tri­als in May 2018 and com­pleted the same in June 2018.

Phase 2 clin­i­cal tri­als to com­mence in the third quar­ter of FY2018-19.

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