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Total 1048 results found. Search for [ FDA ]

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BT Online Bureau
Mumbai, January 27, 2012
The US Justice Department filed a \"ground-breaking\" consent decree in court on Thursday, mandating Indian drug-maker Ranbaxy to adhere to US manufacturing standards.

Washington, January 26, 2012
The decree imposes a number of requirements on Ranbaxy, including implementing procedures to ensure data integrity and hiring a third-party expert to conduct audits of the facilities.
January 19, 2012
Drug maker Ranbaxy Laboratories has reached an agreement with the US health regulator to lift a ban on import of drugs from its certain factories in India.

New Delhi, December 21, 2011
Drug maker Ranbaxy Laboratories on Wednesday said it has reached an agreement with the US health regulator to lift a ban on import of drugs from its certain factories in India, a move which could see the drugmaker pay up to $500 million as fine to the American authorities.

E Kumar Sharma
December 1, 2011
Lipitor, the blockbuster anti-cholesterol drug from Pfizer, went off patent on November 30, 2011. In 2010, revenues from Lipitor were approximately $10.7 billion, a pot that generics companies might now be able to share. 

New Delhi, December 1, 2011
Drug major Ranbaxy Laboratories launches its generic version of blockbuster cholesterol - lowering drug Lipitor in the US market after getting an approval from the US health regulator to manufacture it.

New Delhi, December 1, 2011
The US health regulator's move to grant approval to Ranbaxy Laboratories to produce generic version of cholesterol lowering drug Lipitor will help the India-based firm to launch the drug in the American market.

New Delhi, November 30, 2011
Shares of Ranbaxy Laboratories on Wednesday dropped by nearly 4 per cent amid reports that the pharma major is struggling to get approvals from the US drug regulator to launch generic version of Lipitor.

Associated Press
Tokyo, March 23, 2011
Tap water in Tokyo tested two times above the limit for radioactive iodine considered safe for infants, officials said on Wednesday amid burgeoning concerns about food and water safety.

New Delhi, September 21, 2010
The company will be eligible to enter the US market with its genericversion of Eisai Co's Aricept, the patent for which will expire inNovember this year.

Mudar Patherya
May 16, 2008
The small-cap universe is a treasure trove of bargains— provided you can spot them. Money Today ties up with Trisys Research to identify stocks that aren’t in the limelight, but have the potential to give high returns.

E. Kumar Sharma
July 22, 2010
Multinationals are closing in on Big Pharma, but there are enough mid-size stars as well.

Shalini S. Dagar
July 6, 2010
Two years after it slammed into a US regulatory wall, Ranbaxy Laboratories, under its Japanese owners, is working the hard way to be back among the stars.

Suman Layak
May 26, 2010
For most of its 40 years, Lupin seemed to be just another Indian pharma company trying to make hay in the US generics market. Today, it is a global generics firm to reckon with, taking on giant Teva on the value-creation front.

E. Kumar Sharma
November 15, 2009
While MNCs are invading India in a desperate quest for new markets, Indian pharma firms are struggling to expand and rise up the value chain in a tough, competitive environment.

Virendra Verma
September 3, 2009
India’s most valuable pharma firm has stumbled, as a US subsidiary gets on the wrong side of the FDA and a handful of exclusive arrangements come to an end. Can founder Dilip Shanghvi get Sun Pharma back on the road to supernormal profits?

E. Kumar Sharma
August 19, 2009
By refocussing its strategies, Natco Pharma has pulled back from the brink of bankruptcy to power ahead in cancer drugs. Now it is looking for niche areas globally. Can it scale up and take on global competition?

Rahul Sachitanand
March 5, 2009
Opto Circuits has benefited from operating in the almost recession-proof area of medical devices.

Virendra Verma
March 5, 2009
Sun Pharma rises out of the gloom thanks to its distinctive four-pronged game plan.
December 26, 2008
Battered. Is that the right word to describe Ratan Tata now? The man, who could do no wrong after the twin buyouts of Corus Group and Jaguar-Land Rover, is suddenly looking more human.

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