-The Business Standard The tussle between the US Food and Drug Administration (US FDA) and Ranbaxy is likely to hit the plans of Indian pharmaceutical companies of making it big in the US generic drugs market. Apart from the fact that their image may take a beating, the additional scrutiny on abbreviated new drug applications (ANDAs) from India would lead to more delays in drug approvals. Last week, Ranbaxy had agreed to...
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Ranbaxy's dark chapter-Bhupesh Bhandari
-The Business Standard Why have Indian authorities woken up to the Ranbaxy case only now? The matter had been simmering for several years The Ranbaxy affair is one of the darkest chapters of India's business history. The company has admitted it fudged data so that it could launch its products in the United States. It has now paid $500 million as a penalty to settle the case. It is worse than Ramalinga...
More »Ranbaxy fined $500 m for flawed generics-Narayan Lakshman
-The Hindu Ranbaxy, one of India's largest pharmaceutical companies, has agreed to pay $500 million fines levied by U.S. authorities for selling adulterated drugs and lying to federal regulators in a case that is part of an ongoing crackdown on the quality of generic drugs flowing into the U.S. The deal struck on Monday, said to be the largest financial penalty against a generic drug company for violations of FDA standards, came...
More »In the ‘pharmacy of the world’ -PT Jyothi Datta
-The Hindu Business Line From maker of versions of drugs, India's pharmaceutical industry has turned a top innovator Twenty years ago, Ranbaxy was a home-spun drug-maker. The Indian Patents Act allowed companies to make chemically-similar versions of innovative drugs. Visionaries in the pharmaceutical sector, like Parvinder Singh (Ranbaxy's key architect and member of its promoter family) and Anji Reddy (founder of Dr Reddy's Laboratories), were alive. And the pharmaceutical industry did not have...
More »Domestic firms rejoicing on Glivec verdict-Sushmi Dey
-The Business Standard Now, local firms can sell their low-priced generic version of the drug in India and export it to developing markets, where it is not patented Domestic drug firms such as Cipla, Natco, Ranbaxy and Hetero are a happier lot following the Supreme Court verdict on Monday, dismissing Novartis AG's patent plea for anti-cancer drug imatinib mesylate or Glivec, as sold by the Swiss drug maker. This is because the judgement...
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