Ranbaxy recalls drug in US Jul 10, 2009
The product figured among the 30 Ranbaxy drugs banned by the US Food and Drug Administration (USFDA) in September 2007, but it had allowed the company to sell those drugs which were already in the market since it was not found to be unsafe. ET NOW broke the story on Thursday citing the USFDA website that the companys American subsidiary Ranbaxy Pharmaceuticals was recalling 1,303 cartons of Sotret Isotretinoin, each containing 100 capsules of 40 mg, effective June 26 ... Ranbaxy got the USFDA... (India Times)
Medicos to assist IT firms Mar 30, 2009
Clinical study reports are written for the USFDA for commercial and regulatory purposes. All this is done out of our BPO in India, said Patni BPO head Sanjiv Kapur. (India Times)
Richard Elkins joins Stanbio Laboratory (26) Mar 23, 2009
Stanbio Laboratorys Quality System is ISO 13485 registered and its facility operates under the USFDA current GMP requirements. Stanbio also offers OEM and private labeling capabilities. (Boerne Star, TX)
Iodine Deficiency Disorders Mar 15, 2009
However, a recent study by Purnendu K. Dasgupta et al, Iodine Nutrition: Iodine Content of Iodized Salt in the United States , published in the 2008 Environmental Science & Technology journal, Volume 42, issue 4 revealed the levels of iodine in salt are below the United States Food and Drug Administration s (USFDA) recommended iodine content. Other causes of a low iodine intake and increased iodine deficiency risk include the reduced use of iodine in animal feeds and milk production, and an... (Suite101.com)
Low Iodine Content of Salt in Unite... Mar 15, 2009
The results revealed 47 of the 88 samples (53%) fell below the United States Food and Drug Administration s (USFDA) recommended iodine content. Six containers exceeded the recommended iodine content levels. (Suite101.com)
Australia approves Ranbaxy drug Mar 7, 2009
The office of generic drugs, USFDA, determined the Ranbaxy formulations to be the generic equivalent of Pfizer's Accuretic. This is the second ANDA approval granted by the USFDA in the last two months since the controversy broke out on its drugs manufactured at Poanta Sahib in Himachal Pradesh. (India Times, India -- Intl Business)
Ranbaxy up on clarification from US FDA Mar 2, 2009
"We believe the current USFDA action will have limited impact on Ranbaxys US sales since the import ban on products from the Paonta facilities is already in place since September 2008. Though we had reduced our US sales estimates for CY2009E after the import alert, we would be again reviewing our estimates post the 1QCY2009E results to gauge any further impact of the AIP especially for products, which used clinical data from the Paonta facility," Angel Broking said to its clients recommending... (India Times)
Biotech cos eye Canada, US market Feb 28, 2009
The USFDA has also finished drafting its guidance for biologics, which is pending with the legal department and will be released once the Congress gives its go-ahead , persons familiar with the development told ET.. The USFDA guidance has already been completed. (India Times)
FDA review: Ranbaxy set to lose $150m US revenue Feb 27, 2009
NEW DELHI: Nearly 15% of drug exports to US from Ranbaxy may be adversely impacted as a result of the new USFDA action on the company's Paonta Sahib (Himachal Pradesh) facility ... "Companies must provide truthful and accurate information in their marketing applications. The American public expects and deserves no less," said Janet Woodcock, director of the USFDA's Center for Drug Evaluation and Research (CDER). (India Times, India -- Intl Business)
Ranbaxy falls over 10% on BSE on FDA charges Feb 26, 2009
Meanwhile, Ranbaxy on Thursday said that it has received a letter from USFDA indicating that all pending and approved abbreviated new drug application (ANDA)'s from its Poanta Sahib facility added to 'Application Integrity Policy. The AIP is invoked when a company's actions raise significant questions about the integrity of data in drug applications. (India Times, India -- Intl Business)
