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USFDA scrutiny: Will pharma majors like Ranbaxy, Wockhardt be affected in long-term? -G Seetharaman

-The Economic Times Japanese companies do not mind erring on the side of caution. They are known to think longer and harder than their counterparts in other countries about big decisions, especially when it comes to entering a new market or acquiring a foreign company. But Japan's third biggest drugmaker Daiichi Sankyo would now wish it had spent more time doing due diligence on Ranbaxy Labs, in which it bought a...

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Ranbaxy case may take a toll on other Indian drug makers

-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...

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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...

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Johnson & Johnson’s licence for cosmetics cancelled -Jyoti Shelar

-Mumbai Mirror The Food and Drug Administration (FDA) recently cancelled Johnson & Johnson India's licence to produce cosmetic products at their Mulund plant. FDA's order will come into effect from June 24. According to FDA officials, the order was issued in a case dating back to 2007 when they found that 15 batches of Johnson & Johnson baby powder were sterilised by ethylene oxide, a known carcinogenic and irritant. "While ethylene oxide can...

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