While the run-in with the USFDA
is top priority, it is not the company's only headache at the moment.
For instance, in February last year the Indian government had expressed concern over the manner in which the USFDA
was carrying out audit inspections of Indian pharmaceutical companies and in some cases announcing major penalties without even waiting for the clarification from these firms to come through.
Resultantly, M/s Ferozsons Laboratories submitted the technical and stability data conducted by M/s Gilead Sciences, Canada and approved by various regulatory authorities including USFDA
, Australian TGA and European Medicine Agency, which was found the most authentic and well establish the drug quality, efficacy and safety.
Based on the USFDA
Recall Notice, Gala and Granny Smith Apples are produced/exported by US company Bidarth Brothers.
According to a statement by Sri Lankan Embassy in Washington, "The USFDA
requires all domestic and foreign food facilities to renew their FDA registration every even numbered year.
Mr Bruce Ross, India country director of the USFDA
, who was present at the Congress had suggested that initiatives on such a massive scale will be supported by USFDA
since such initiatives on aquaculture in Bangladesh has yielded promising results.
The expanded indication approved by the USFDA
is based on immune responses elicited by Prevnar 13, and there have been no controlled trials in adults demonstrating a decrease in pneumococcal pneumonia or invasive pneumococcal disease after vaccination with Prevnar 13, said the report.
The company's facilities have approval from European Directorate for Quality of Medicine & Healthcare (EDQM) since 2005, while one of the six production units at the Baroda facility received USFDA
approval in October 2009 for Venlafaxeine HCL (used in treating antidepressants).
Forty-seven of 88 samples fell below the USFDA
recommended I content while 6 exceeded it.
The Dominican pharmaceutical industry will take a big step forward when the USFDA
(Food and Drug Administration) gives its stamp of approval to the preliminary "pre-approval" of Magnachem Laboratories, reports DR1 Daily News (March 27, 2006).
The Partnership unites industry associations, consumer and public health groups, and USDA, CDC, USFDA
, and USEPA to educate the public about safe food handling and preparation.
Various symbols denote USFDA
approval, randomized controlled trials, case series and case reports.