The recent FDA warning letter to Ohm Laboratories, in which the regulator calls "inadequate" the company's corrective measures to fix GMP violations, has left the company in a precarious position. Following three responses to the FDA after a detailed inspection of Ohm's Gloversville, NY, facility (as reported earlier) the company now must redouble its efforts to restore its credentials as a U.S. drug supplier. Ohm is the U.S. arm of Indian generics maker Ranbaxy, now owned by Japan's Daiichi Sankyo.
"It is indeed a poor reflection on how the company is dealing with an extremely serious condition," writes pharma columnist "Pillman," who is identified in Mumbai-based DNA (Daily News & Analysis) as a global pharma executive. Pillman speculates that if the FDA needs to take additional action, it is likely to surpass a strongly worded letter.
The columnist acknowledges that Ranbaxy has hired manufacturing consultancy PRTM to help get itself on track. So that places it a step ahead of Caraco--the U.S. arm of India-based generics maker Sun Pharmaceutical Industries--which starred as the 2009 poster child for a tougher FDA. Caraco did not hire a consultant until it was court-ordered to do so, following seizure by U.S. marshals of products and inventory from facilities in Detroit.
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