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The US Congressional committee, which is inquiring into the country's Food and Drug Administration's handling of drug-marketing approvals of India's leading drug-maker Ranbaxy, has extended its probe into similar permissions given to Iceland's Actavis.
Ranbaxy's shares jumped almost 10 per cent, having long been depressed by escalating investigations from the US Food and Drug Administration, triggering a ban, which is still in place, that stops the US importing or purchasing the company's drugs. Daiichi Sankyo, the Japanese drugmaker, reiterated on Wednesday that it would stick to its June offer to buy Ranbaxy in spite of its recent troubles.
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The domestic drug industry is concerned over ongoing World Health Organisation negotiations that aim to bring non-health issues, having no direct implications on the safety of a drug, within the ambit of the definition of "counterfeit medicine".
The first petition alleges that Cipla Ltd, India's second largest pharmaceutical company, violated Roche's patent by launching a generic version of Valcyte. The second petition says Cipla violated the Swiss drug maker's trademark by launching the product in a phonetically similar name, 'Valcept'.
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The US Food and Drug Administration has issued two warning letters to Ranbaxy claiming procedural violations at its plants in Dewas and Paonta Sahib in India. Giuliani, a high-profile Republican leader and former US attorney in Manhattan, would provide advice and review compliance issues. Ranbaxy has been accused of selling generic drugs which did not meet FDA standards.
What has worked though for Brand Saridon has been its single-minded focus on headaches as opposed to other analgesics that dwell on a wider set of problems, reports Sohini Das.
Dr Reddy's has reached an out-of-court settlement to launch the Glaxo-patented Imitrex, a migraine drug that had annual sales of $878 million as of March 31, 2006, in the US. Experts estimate Dr Reddy's may not get more than $8-$15 million sales in 2009 since majority of sales revenue has to be given to GSK, for allowing the launch the authorised generic version.
Dilip Shanghvi founded Sun Pharma in 1983.
The death of a participant in a clinical trial by a Hyderabad-based contract research firm has refocused attention on the practices followed by an industry which is said to have great promise, because it can earn good dollars by leveraging cheap Indian skills.
The US Food and Drug Administration (USFDA) has asked Caraco Pharmaceutical Laboratories, the US subsidiary of Mumbai-based Sun Pharmaceuticals Industries, to withdraw many batches of its generic Metformin Hydrochloride tablets used for treating diabetes, citing efficacy and quality issues. According to a USFDA Class II withdrawal announced on March 19, Caraco will have to withdraw seven lots of Metformin Hydrochloride in bottles of 100, 500 and 1000 tablets each.
Three leading international pharma companies have started due diligence to acquire Wockhardt Ltd's wholly-owned Irish generic drug company, Pinewood.
Pharmaceutical majors like Ranbaxy, Dr Reddy's Lab, Wockhardt, Glenmark and Sun Pharma are now treading a careful patent litigation path in the US market to expand their generic business instead of the aggressive patent challenges they pursued until a few years ago.
The company has got the approval for the generic version of Roche's anti-viral 'Valcyte', which has a total annual market of around $239 million. Ranbaxy believes that it has First-to-File status on Valganciclovir tablets, thereby, providing a potential of 180-days of marketing exclusivity which offers a significant opportunity in the future, the company said.
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India's largest drug maker Ranbaxy Laboratories, which is fighting a patent battle with the world's largest drug maker Pfizer on the cholesterol lowering drug Lipitor in about 18 countries, got a mixed verdict from the Full Court of Federal Court of Australia.
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Sun generates 41 per cent of its annual revenues from the US market, a record of sorts among Indian drug firms. The company is bullish on its US prospects and expects 25 per cent growth in the country this year, higher than the 18-20 per cent growth projection it has given for other markets including India. The US is the world's largest market for medicines and accounts for nearly 50 per cent of the $780 billion global medicine sales.
Better-than-expected financial results in Q3 due to higher revenue growth and margins in key markets fuel the rally
The Finland-based drug major Orion Corporation has filed a lawsuit in the United States against domestic drug major Wockhardt for challenging the patents on its brand Stalevo, used for the treatment of Parkinson's disease.
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The Rs 3,290 crore (Rs 32.9 billion) Sun plans to sell Topamax in four strengths ranging from 25mg to 200mg, the combined market for which is estimated to be $2.5 billion. There is, of course, no litigation with the patent holder OrthoMcneill Janssen. The US market, which brings in about 40 per cent of Sun's consolidated sales and has driven revenues in the past few year could lose momentum.
The joint entity will have a market share of nine per cent in India. Analysts tracking the company said one of the key outcomes of the merger would be to create a single brand entity of Sun and the Ranbaxy brand would eventually dissolve.
The FDA Commissioner Margaret Hamburg is slated to travel to India soon.
Successive governments focused on altering the clearance processes but largely gave a pass to the second, and essential, element of environmental regulations for monitoring pollution levels and how industries followed conditions laid down for clearances.
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Singh said they will focus on Fortis Healthcare and Religare Financial Services after the acquisition.
Ranbaxy Laboratories, Dr Reddy's, Nicholas Piramal and three other Indian drug companies cut their research costs by separating the units involved in developing new drugs, thereby addressing investor concerns on low operating margins.
Ahmedabad-based Zydus Cadila, India's fourth largest pharma company with a turnover of Rs 2,300 crore, has acquired 100 per cent stake in Laboratorios Combix of Spain, marking its entry into Europe's fifth largest pharmaceutical market. The company bought the Spanish firm for an undisclosed amount.
Israel's pharma firm, Teva, is planning to invest Rs. 4000 crores in India.
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Drug major Ranbaxy Laboratories could suffer a potential revenue loss to the tune of Rs 300 crore (Rs 3 billion) due to delay in receiving approval from the US Food and Drug Administration (FDA) for generic version of GSK's anti-migraine medicine Imitrex, according to analysts.
Retail sales of Ranbaxy Laboratories, Cipla, Nicholas Piramal, Lupin and other drug makers have jumped by over 10 per cent in the domestic market despite the sales of generics or copycat versions of patented drugs falling in leading global markets such as the US and Europe.
Educational institutions in Canada offer courses ranging from eight months duration to two years, says Sushil Sukhwani
In its ongoing patent litigation over cholesterol lowering drug atorvastatin (Lipitor) against India's Ranbaxy Laboratories, Pfizer said on Tuesday in a court in Ireland had ruled in its favour.
I saw a fantastic Aamir Khan film the other night, one where his obsession with a pretty woman led to him being clubbed on the head with a generic looking rod.
The drug regulatory agencies of India and Canada are planning to collaborate on improving the quality of drugs traded between the two countries, besides helping the industry in both the countries to tap the opportunities in the field of generic medicines and drug development.
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