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Ranbaxy Laboratories hit again as US FDA bans more products

Last Updated: Friday, January 24, 2014, 06:07

In a setback to Indian pharmaceutical giant Ranbaxy, the US has prohibited the company from producing and distributing drugs for the American market from its Toansa facility in Punjab.

Ranbaxy shares falls on USFDA concerns

Last Updated: Tuesday, January 14, 2014, 11:57

Ranbaxy Laboratories shares fall 1.3 percent, adding to Monday`s 5.4 percent slump after the U.S. Food and Drug Administration raised concerns about manufacturing practices at one of its factories.

FDA raises more concerns about Ranbaxy's India plants

Last Updated: Monday, January 13, 2014, 15:41

The company, India`s biggest drugmaker by sales, said the FDA had now filed "certain observations" about its Toansa pharmaceutical ingredients plant in Punjab.

FDA, European regulators to cooperate on generic drugs

Last Updated: Thursday, December 19, 2013, 02:48

US and European drug regulators will work together on joint inspections around the world to try to make sure consumers are buying generic medications that are both safe and effective, the US Food and Drug Administration said on Wednesday.

Drugmakers urge FDA security audit after cyber breach

Last Updated: Wednesday, December 18, 2013, 07:26

The US Food and Drug Administration is under pressure from the pharmaceutical industry and lawmakers to undergo an independent security audit, after hackers broke into a computer system used by healthcare companies to submit information to the agency.

US generic drug fee relief plan may benefit Indian companies

Last Updated: Sunday, December 15, 2013, 12:29

The US regulations require companies to pay user fees to supplement the costs of reviewing generic drug applications and inspecting facilities.

Several Indian cos get FDA nod for anti-depressant drug

Last Updated: Thursday, December 12, 2013, 10:25

In a major boost to some of the Indian drug makers, the US Food and Drug Administration has approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used in treatment of depression and other conditions.

FDA asks Wockhardt to conduct global assessment of its plants

Last Updated: Wednesday, December 4, 2013, 09:53

Of late, the FDA has targeted the largest Indian drug manufacturing producers including Ranbaxy.

US FDA for greater freedom to generic cos in product labelling

Last Updated: Sunday, November 17, 2013, 18:46

Generic manufacturers, which make cheaper but therapeutically equivalent versions of innovative drugs, would be required to inform the brand name manufacturer about the labelling change.

Ranbaxy falls about 30% after FDA import alert

Last Updated: Monday, September 16, 2013, 10:03

A third Ranbaxy Laboratories plant in India has been sanctioned with an import alert ban from the US Food and Drug Administration, triggering the worst single day fall in its stock on Monday and a brokerage downgrade.

Indian companies among firms yet to pay annual facility fees to FDA

Last Updated: Friday, September 6, 2013, 16:32

India is the second largest drug exporter to the US.

FDA warns 2 Indian firms for manufacturing lapses

Last Updated: Sunday, August 25, 2013, 18:40

In its latest action against Indian drug makers, the US health regulator FDA has red- flagged "significant deviations" from good manufacturing practices at two Indian pharmaceutical companies.