USFDA has granted Ajanta Pharma 9 ANDA final approvals and two tentative approvals. Additional 15 ANDAs are under review with the American regulator
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The company said it is eligible for 180 days of shared generic drug marketing exclusivity for rufinamide tablets
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Lupin has benefitted in recent months from a steady pace of new drug approvals in the United States at a time when most of its peers have been facing delays in getting approvals due to regulatory troubles
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Indian officials say they have proposed an oil-for-drugs barter plan with cash-strapped Venezuela to recoup millions of dollars in payments owed to some of India's largest pharmaceutical companies
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Dr Reddy's said it took a hit of $65 million in the January-March quarter because it could not get approval from the Venezuelan government to recover any more money beyond the $4 million it has already received
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Combiflam is a combination of paracetamol and ibuprofen, and is one of Sanofi's five biggest brands in India
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The erstwhile promoters of Ranbaxy Laboratories, the Singh brothers and family have been asked to pay damages of Rs 2,562.78 crore to Daiichi by an arbitration tribunal in Singapore for concealing and misrepresenting information during their stake sell to the Japanese firm
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Pfizer's approach comes less than a week after Sanofi went public with its $52.50 per share cash offer, complaining that Medivation refused to engage.
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This situation is unique to India, where sales growth of companies is closely connected to brand launches
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Sri Krishna Pharmaceuticals, a supplier of paracetamol and other drugs to more than 60 countries, has been warned by the US Food and Drug Administration, which cited manipulation of its test results at a plant
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