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ANDAs Approvals from USFDA

Indian companies received approval for 201 Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (FDA) out of total 598 ANDA approvals. Thus, the Indian companies grabbed almost 34 per cent of total final approvals during 2016. Further, out of total 156 tentative approvals, Indian companies secured 70 approvals during 2016 which worked out to 44.9 per cent of total tentative approvals. 

During the last decade US FDA approved 4,666 ANDAs and Indian companies received final approval for 1,524 ANDAs, which worked out to almost 33 per cent. Similarly, total tentative approvals during last decade worked out to 1,101 and out of this Indian companies received 430 tentative approvals, over 39 per cent.

The R&D expenditure of leading 25 Indian Pharma Companies increased by 24 per cent to Rs.11,710 crore during 2015-16 from Rs.9,439 crore in the previous year and these companies established strong presence in highly regulated markets and the same trend is likely to continue in 2016-17. 

Indian companies secured 33.6 per cent of total ANDAs approved by US FDA during 2016. In absolute term Indian companies such as Aurobindo, Glenmark Pharma and Sun Pharma remained as top three companies with higher ANDA approvals.

Aurobindo received highest number of approvals for 58 ANDAs during 2016 followed by Glenmark Pharma 18 ANDAs and Sun Pharma and Taro Pharma also secured 18 ANDA approvals, of which Sun Pharma received 10 ANDA approvals. Lupin grabbed 11 ANDAs. The R&D expenditure of Aurobindo Pharma went up by 23 per cent to Rs.443 crore during 2015-16 from Rs.360 crore in the previous year. Glenmark's R&D spending went up by over 36 per cent to Rs.818 crore from Rs.601 crore and that of Lupin went up by 55 per cent to Rs.1,732 crore. Sun Pharma's R&D expenditure moved up by 17.8 per cent to Rs.2,303 crore from Rs.1955 crore in the previous year. The R&D investment of these companies also increased in the first half of 2016-17.

Among the tentative approvals, Aurobindo received 16 approval followed by Lupin 10, Alkem 6, Strides 5, and Alembic Pharma, Glenmark Pharma and Macleods Pharma 4 each during 2016.