Lupin, the third largest Indian pharma giant with net sales over Rs.12,500 crore, has suffered heavy setback today due to US FDA inspection and its observations. Lupin scrip touched to its yearly low level at Rs.1,294.05 today in the morning session on BSE as compared to its yearly highest level of Rs.2,127 in October 2015. The scrip declined sharply by over Rs.200 as compared to previous day's close of Rs.1,495.20. However, it recover losses afterward. The company stated that the US FDA inspected its Goa facility and cited 9 observations regarding inadequacy and adherence to standard operation procedures (SOPs).

United States is Lupin's largest market and contributed 45 per cent of its revenues during 2014-15. Its generic sales improved by 12 per cent to US$ 811 million despite stiff competition and slowdown of product approvals in the US. It launched 11 new products, including the successful commercialization of generic versions of Monodox 75 mg and Celebrex. The US FDA observations may impact the working of company in the near future.  

For the nine months ended December 2015, Lupin's consolidated net sales increased only by 0.7 per cent to Rs.9,610 crore from Rs.9,546 crore in the similar period of last year. Its net profit declined sharply by 21.1 per cent to Rs.1,464 crore from Rs.1,856 crore. EBIDTA declined by 16.5 per cent to Rs.2,548 crore from Rs.3,053 crore. EPS declined to Rs.32.52 from Rs.41.37 in the last period.

Its international sales declined by 0.8 per cent to Rs.6,989 crore from Rs.7,043 crore and that in India improved by 14.7 per cent to Rs.3,038 crore.  Its R&D expenditure increased by 38.5 per cent to Rs.1,093 crore from Rs.789 crore.

It filed 5 ANDas during the third quarter and received 9 approvals from the US FDA. Cumulative ANDA filings stood at 225 and it received total 133 approvals. The company has 37 first-to-file products which includes 17 exclusive FTF opportunities.