110 FDA approvals for Indian drugs

Indian pharma companies have got more than 100 USFDA approvals in 2013 so far.


New Delhi, September 16, 2013: Indian pharma industry, the biggest overseas source of medicines sold in the US, has received over 100 generic drug approvals so far this year from the US Food and Drug Administration (FDA). The recent approvals have taken India's share in the Original Abbreviated New Drug Application (ANDA) approvals to nearly 40 per cent in the US market so far in 2013.


Since the beginning of 2013, the USFDA has approved nearly 290 ANDAs allowing pharmaceutical firms to manufacture and sell generic drugs as a safe, effective and low cost alternative to the American drugs. The US market is home to generic drug spending worth US$ 300 billion every year and India produces close to 40 per cent of generic and over-the-counter products while its share in the finished dosage medicine segments is about 10 per cent.


It is interesting to note that India has over 150 FDA-approved plants, including facilities run by MNCs and shipped pharma products worth over US$ 4 billion to the US in 2012, year clocking a growth of around 30 per cent from the previous year.


* Indicates mandatory field.
Please wait while comments are being sent...