Fifty-one of the 112 approvals for abbreviated new drug applications (ANDA) given by the USFDA went to India. Further, Indian companies received 6 tentative approvals from an aggregate of 23 tentative approvals in the Jan-March quarter of 2018.
With eleven ANDA approvals, Aurobindo Pharma received the highest number among the Indian companies. It is followed by Strides Shasun with six, Lupin with five, Cipla and Zydus Pharma got four each, Dr Reddy’s Laboratories, Hetero Labs, and Taro Pharma secured three each. Macleods Pharma and Vivimed Global received two approvals each. Alkem Laboratories, Gland Pharma, Glenmark Pharma, Granules India, Jubilant Life, Laurus Labs, Micro Labs, and Torrent Pharma received one ANDA approval each in the first quarter.
Many Indian pharma companies invest significant amounts in R&D expenditure to meet international competition and they file new products in highly regulated markets such as U.S. and Europe. Lupin, Dr Reddy’s Laboratories, Alkem Laboratories, Biocon, Cadila Healthcare, Sun Pharmaceuticals, Ajanta Pharma, among others are ready to compete in the international pharma market.
Last updated: December 26th, 2025
