Dec 08, 2014 at 21:14 | Source: PTI
The nationwide recall has been initiated by the company on October 1 this year and has been initiated under Class-III which FDA defined as "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences".
Dec 02, 2014 at 08:34 | Source: Moneycontrol.com
Sun Pharma Advanced Research Company announced that the US Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for Latanoprost BAK-free eyedrops.
Nov 26, 2014 at 14:34 | Source: PTI
Ranbaxy Laboratories had sued USFDA over revoking an approval to sell generic versions of Nexium and Valcyte in the US market.
Nov 21, 2014 at 11:33 | Source: Moneycontrol.com
The brokerage says Cipla aims to grow its sales from USD 1.6 billion to USD 5 billion by FY20 (21 percent compounded annual growth rate - CAGR).
Nov 18, 2014 at 14:55 | Source: Reuters
In the suit filed in the District Court for the District of Columbia, Ranbaxy said the FDA's move violated constitutional rights, exceeded the agency's statutory authority, and was "arbitrary, capricious, and otherwise contrary to law."
Nov 12, 2014 at 12:42 | Source: Reuters
Cadila Pharmaceuticals is the latest Indian drugmaker to face US regulatory rebuke, as the FDA intensifies its scrutiny of the generic drugmakers.
Nov 12, 2014 at 08:34 | Source: Reuters
India's USD 15 billion pharmaceutical industry, which has been hit by a spate of regulatory sanctions in the past year due to concerns about production processes, supplies about 40 percent of generic and over-the-counter drugs to the United States.
Nov 10, 2014 at 12:16 | Source: CNBC-TV18
For the largecap pharma companies the game has become completely US-cued. So, US will be the driver for Dr Reddys and Lupin, says Anmol Ganjoo.
Nov 10, 2014 at 11:10 | Source: Moneycontrol.com
Taro's gross profit, as a percentage of net sales, was at 79 percent compared to 77.7 percent. During the quarter, operating income increased USD 40.0 million to USD 160.3 million, or 63.9 percent of net sales, compared to 58.6 percent of net sales.
Nov 07, 2014 at 11:21 | Source: Reuters
The US Food and Drug Administration (FDA) said it has granted final approval to Indian drugmaker Dr Reddy's Laboratories and US firm Endo International Plc to make cheaper copies of Roche Holding AG's antiviral Valcyte.