It is calm and quiet at Aurobindo Pharma office in Hyderabad’s Kondapur area. As we step into one of the meeting rooms, it is hard to miss a few stern-faced foreigners moving around. They are busy poring over files and make limited conversation. “This is a routine USFDA audit,” says M Madan Mohan Reddy, the company’s director, in a hushed tone. As he settles down for a chat, we think back to the number of pharma companies that have received FDA warnings in the past year. Unsurprisingly, Reddy begins by talking about an episode in mid-2011, when his company received an FDA quality-warning letter for non-sterile products at its antibiotics manufacturing plant in Hyderabad. “It was a big setback but also a learning experience,” Reddy admits.
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