The US drug regulator has opposed American firm Mylan’s request to strip Ranbaxy Laboratories of its six months exclusive right to sell a low-priced version of the world’s best-selling drug Lipitor in the US. The US Food and Drug Authority (FDA) has in principle allowed Ranbaxy to sell a generic version of the medicine from end of 2011, after original drugmaker Pfizer’s patent expires in November.
The six months headway can bring in as much as $500-600 million in revenues for India’s largest drugmaker. Last month, Mylan moved a local US court saying that FDA’s approval to Ranbaxy should be quashed as the Indian firm isn’t eligible for the marketing exclusivity since it submitted false and unreliable data from its Poanta Sahib plant.
The FDA in its reply said it is for the regulator to determine if Ranbaxy’s application should be approved or not. Ranbaxy, now owned by Japan's Daiichi Sankyo, is yet to get final approval from the FDA for the drug even as it continues to work on a comprehensive settlement with the regulator.crackcrack
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1807.25 |
| Dr. Reddys Lab | 1273.90 |
| Cipla | 1388.80 |
| Zydus Lifesciences | 1104.35 |
| Lupin | 2292.70 |
| View more.. | |
MoneyWorks4Me is a SEBI-registered Investment Adviser (IA) dedicated to helping investors build long-term wealth through transparent, research-driven, conflict-free guidance. Founded in 2008, we started our journey as a Research Analyst (RA), providing deep fundamental analysis, intrinsic value insights, and long-term investing frameworks for Indian equities. In 2017, we transitioned to a full-fledged SEBI-registered Investment Adviser, strengthening our commitment to acting as a fiduciary—always putting the investor’s interest first.
To become India’s most trusted, research-powered fiduciary advisory platform—where every investor, regardless of experience, can make calm, confident, and well-reasoned investment decisions.
MoneyWorks4Me ensures this through: