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USFDA issues warning letter to Sharon Bio-medicineThe US regulator has issued a warning letter to Sharon Bio-medicine for failing to pay generic drug user fee by its owner for three years.- US FDA asks Indian pharma leaders to make quality, their top priority"Companies must ensure that they are saying what they do and they do what they say and demonstrate that they did it" said Leslie Ball of FD...
- Innovator or generic, building quality will build reputation: Margaret HamburgUS Food and Drug Administration Commissioner Margaret Hamburg is currently in India on her first official visit to the country.
- USFDA increases inspections of drug facilities in IndiaUSFDA is increasing its inspections of facilities of drug makers in India to ensure compliance of approved manufacturing norms.
- US FDA asks Indian drugmakers to comply or face actionThe US Food and Drug Administration also warned of "appropriate action" against the companies who fail to implement "Good Manufacturing Pra...
- We trust indian manufacturing norms: USFDAFDA’s statement comes as a validation of the claim by Indian drug manufacturers who had maintained that Ranbaxy’s $500 mn settlement was an...
- Pharmexcil asks for clarity from US Regulator on generic drug fee normsThe Pharmaceutical Export Promotion Council of India (Pharmexcil) has sought clarity from the United States Food and Drug Administration (U...
- Pharmaceutical Export Promotion Council of India seeks clarity from US on new generic drug fee normsPharmexcil has sought clarity from the United States Food and Drug Administration (USFDA ) on the new generic drug user fee norms.
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