During the first six months of 2013 Indian generics companies received 87 final approvals for abbreviated new drug applications (ANDAs) as well as 25 tentative approvals from US FDA. This represents 41% and 53%, respectively, out of the total of 211 final ANDA approvals and 47 tentative ANDA approvals.

Aurobindo Pharma and Sun Pharmaceuticals topped the chart, with both gaining approval of 15 ANDAs during the first half of 2013, see Table 1. This was closely followed by Lupin, which achieved 11 ANDA approvals.

Table 1: ANDA approvals for the period of January to June 2013

The numbers are looking good in 2012, where Indian companies received 178 ANDA approvals out of a total of 476 and 42 tentative ANDA approvals out of a total of 94. This corresponds to 37% and 45%, respectively, for the full year. Therefore, if the percentages stay the same for 2013, i.e. 41% and 53%, respectively, this looks set to be a bumper year for approvals for Indian generics companies once again.

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