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.