Indian pharmaceutical companies bag 40 per cent of ANDAs approved by USFDA: Report

According to a report by CentrumBSE 4.66 % Broking, Indian pharma companies bagged around 40% of all Abbreviated New Drug Approvals (ANDA) approvals from the US Food and Drug Administration (FDA) between January and July 2013. ANDA approval is a pre-requisite for marketing generic products in the US. Among the Indian companies, Sun PharmaBSE 1.08 % and Aurobindo PharmaBSE 1.40 % emerged the winners with 21 and 20 ANDA approvals respectively.

Indian pharma companies bagged around 40% of all Abbreviated New Drug Approvals (ANDA) approvals from USFDA between January and July 2013.

This augurs well for the Indian pharma industry, which is poised to benefit from the approvals coming at a time when rupee has faced its steepest depreciation against the US dollar. The US performance of most export-oriented pharma companies has been quite strong in the last two quarters. In the current scenario of weakening rupee, the export-oriented sector is likely to perform better than most other sectors – thanks to better realisations from the US market. Companies like Sun Pharma, LupinBSE 5.05 %, Ranbaxy and Dr Reddy’s Labs earn majority of their revenues from the US.

However, some companies like CiplaBSE -0.31 % have warned that the benefit may not last long since the companies would be expected to give bigger discounts on their generics to remain competitive.