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Indian drug makers face heat of US regulator's crackdown-Sushmi Dey

-The Business Standard Data also show that several other leading domestic pharma companies have recalled their products from the US Frequent drug recalls, warning letters and import alerts from the US in the recent past have turned into a major concern for the Indian pharmaceutical industry and investors. While Ranbaxy Laboratories recently pleaded guilty before the US authorities for its wrongdoings in the past, the crackdown on the drug companies seems to...

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Who Manufactures Dirty Medicines?-Amit Sengupta

-Newsclick.in A few weeks back Fortune magazine and CNN carried a long online blog titled ‘Dirty Medicine' by Dinesh Thakur, a former employ of Ranbaxy, where he recounts how he came across several procedural and other lapses in the company's manufacturing facilities. Since then the Fortune blog has become one of the most widely circulated and commented upon business stories in the world. The story received attention as it came in the...

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EU fines Ranbaxy, others for blocking cheaper drugs

-Reuters BRUSSELS: Nine drugmakers, including Denmark's Lundbeck and India's Ranbaxy, were fined a total of 146 million euros by EU antitrust regulators on Wednesday for blocking the supply of a cheaper anti-depressant medicine to the market. The punishments follow a 2009 report by the European Commission on the pharmaceutical sector, which said "pay-for-delay" deals lead to consumers paying as much as 20 percent more for their medicines. The EU action came two days...

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We trust indian manufacturing norms: USFDA -Divya Rajagopal

-The Economic Times MUMBAI: The United States Food and Drug Administration (USFDA), widely considered the world's most stringent regulatory authority, has said India's share in generic exports to the US over the years is an indication of the good manufacturing norms practised by Indian drugmakers. As the Ranbaxy scandal threatens to tarnish India's image as a hub of manufacturing world-class generic drugs, the statement, by USFDA's spokesman Chris Kelly in an...

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US drug regulator detects lapses in Hospira's TN unit -Rajesh Chandramouli

-The Times of India CHENNAI: The US Food and Drug Administration (FDA) has rapped pharma giant Hospira for serious lapses in manufacturing of drugs at its Sriperumbudur unit. The US agency has warned the firm that this could result in drugs made at the plant not being allowed entry into the US. Hospira, in a regulatory filing, said it had received a warning letter from the agency . The letter followed an...

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