Tor­rent Pharma

BioSpectrum (India) - - COVER STORY -

The R&D Cen­tre at Tor­rent Pharma is en­gaged in the dis­cov­ery of New Chem­i­cal En­ti­ties (NCEs), de­vel­op­ment of new pro­cesses for known Ac­tive Phar­ma­ceu­ti­cal In­gre­di­ents (APIs) and de­vel­op­ment of value - added & dif­fer­en­ti­ated for­mu­la­tions by lev­er­ag­ing the pro­pri­etary tech­nolo­gies for which patents have been filed. Dur­ing FY2018, the com­pany has in­vested Rs 3.69 bil­lion for the R&D. Till date, Tor­rent has filed 107 ANDAs and 37 DMFs in US and 70 new prod­uct dossiers and 27 DMFs sub­mit­ted in EU. The com­pany is cur­rently work­ing on sev­eral in-house NCE projects within the ar­eas of metabolic, car­dio­vas­cu­lar, gas­troin­testi­nal, der­ma­to­log­i­cal and res­pi­ra­tory dis­or­ders.

Key High­lights – FY2018

Re­ceived 6 ANDAs ap­provals.

NCE for the re­duc­tion of car­dio vas­cu­lar risk is cur­rently un­der­go­ing the piv­otal Phase III clin­i­cal trial in key mar­kets.

Com­pleted Phase II clin­i­cal trial for di­a­betes as­so­ci­ated heart fail­ure in In­dia and Eu­rope. Optimizing the for­mu­la­tion, be­fore em­bark­ing on the piv­otal phase III clin­i­cal trial next year.

Reg­u­la­tory fil­ing for the Phase II study for third NCE be­ing de­vel­oped for in­flam­ma­tory bowel dis­ease is planned this year.

First NCE for the in­di­ca­tion of COPD (Chronic Ob­struc­tive Pul­monary Dis­ease), is com­plet­ing the IND (In­ves­ti­ga­tional New Drug) en­abling tox­i­c­ity stud­ies to sup­port first-in-hu­man stud­ies.

Work­ing on in­di­ca­tion of acute pain man­age­ment through nasal route of de­liv­ery. This pro­gram has ad­vanced in to Phase I clin­i­cal de­vel­op­ment.

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