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.