Drug companies in the US are carefully evaluating their portfolios to give away approvals for those products that are not commercially viable, as these approvals are not free anymore.
US, once a market where generic pharma companies had to fight to retain generic drug approvals, is now seeing companies willingly giving them away - that includes Indian pharma majors like Ranbaxy , Dr Reddy's & Aurobindo Pharma reports CNBC-TV18's Archana Shukla and Farah Bookwala Vhora.
Drug companies in the US are carefully evaluating their portfolios to give away approvals for those products that are not commercially viable, as these approvals are not free anymore. The USFDA has started charging a generic drug user fee (GDUFA), which amounts to about Rs 20-25 lakhs for approving a generic drug application.
Also read: USFDA boost for Ranbaxy; see akin deal for Nexium: Dandekar
Consequently, a recent update from the USFDA says almost 86 generic drug approvals were voluntarily withdrawn by multiple pharma companies. Three Indian drug firms were also part of the list.
1) Aurobindo withdrawing approvals for six Cephalosporin products, from Unit 6, which was banned by the USFDA.
2) Ranbaxy withdrew four approvals for products filed from its erstwhile facility in Gloversville.
3) Dr Reddy's withdrew two approvals at their end.
Analysts feel this has helped contain aggressive and unnecessary generic drug filings made especially by Indian companies.
In fact, experts say even with the recent consolidation of pharmacy chains in the US, generic drug makers will continue to be in a competitive landscape where number of drug filings will eventually become less important - the reason why we see pharma companies like DRL, Sun Pharma , Aurobindo, Lupin , slowly maturing now to focus on niche therapies and complex generics approvals, where there is better certainty of securing a good market share.
Ranbaxy Labs stock price
On June 27, 2014, Ranbaxy Laboratories closed at Rs 497.15, up Rs 25.40, or 5.38 percent. The 52-week high of the share was Rs 510.45 and the 52-week low was Rs 253.95.
The latest book value of the company is Rs 3.41 per share. At current value, the price-to-book value of the company was 145.79.
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