New Delhi: Ranbaxy Laboratories has started shifting production of its generic version of the world's bestselling drug Lipitor from the US to its new manufacturing facility in Mohali, besides filing applications to launch generic versions of blockbuster drugs from its local plant.
"There are more approvals coming through and will come through from Mohali facility because quite a bit of our regulatory submissions in the recent times have gone from Mohali," the company's CEO and MD Arun Sawhney said in a post-results briefing.
The company has largely shifted production of atorvastatin, its generic version of Lipitor, to Mohali in Punjab, Sawhney said. The company raked in about $600 million from sale of atorvastatin in the US during a six-month exclusivity, a period when no other generic company can sell their low-cost version of the drug in the country.
According to an industry executive familiar with the development, India's biggest drug maker has also sought US Food and Drug Administration's (FDA) approval to market its generic version of Novartis' $6 billion hypertension drug Diovan from the Mohali plant.
Just as in the case of atorvastatin, Ranbaxy enjoys a 180-day marketing exclusivity for the drug by virtue of being the first to successfully challenge Novartis' patent for Diovan. The company is confident of launching the drug in September.
"We have augmented our abbreviated new drug application submissions in the US and going forward we will be filing more products from the Mohali facility, in addition to Ohm," a company spokesperson said, while declining to comment on whether the company had filed the application from its India facility.
Ranbaxy has about eight key similar opportunities, known as first-to-file applications, due for launch over the next year or two. It is crucial for Ranbaxy to monetise these opportunities to drive its growth, particularly since growth of its core business has stagnated in several markets.
During the April-June quarter, its US sales of $255 million, boosted by revenues from atorvastatin, accounted for more than half of its global sales of $588 million.
Similarly, generic Diovan has the potential to generate $100-$150 million in revenues during the six-month exclusivity period, according to the estimate of a Mumbai-based brokerage house. "Manufacturing in India will also mean about 10% higher profitability," said the pharma analyst of the firm, adding that Ranbaxy has so far filed marketing applications for about 10 drugs from Mohali plant, which is being gradually ramped up.
Though Ranbaxy signed a consent decree earlier this year with the US authorities, it could be few years before it can resume supplying medicines to the US from its two FDA-approved Indian plants. In 2009, Sun Pharmaceuticals signed a similar decree with the US authorities for one of its plants in the US but is yet to get the FDA's nod to resume supplying drugs from that plant to the US market.
Ranbaxy's other FDA-approved plant in Ohm facility in New Jersey is also fully utilised, leaving the company to depend on its new plant for expansion. Ranbaxy said it will manufacture tablets, capsules and dry syrups in Mohali to mainly cater to regulated markets such as the US, EU and Japan.
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