Approval for more than 60 ANDAs pending: DRL

Pharma company Dr Reddy’s Laboratories is facing hurdles due to lack of regulatory issues. The company’s API plant in Vizag has received nine 483s from the USFDA. However, in the previous week when the company finished another dosage for an adjacent facility in Vizag with zero 483, media failed to report the issue, says the President and CFO Saumen Chakraborty. According to him, approval for more than 60 abbreviated new drug application (ANDA) is still pending.

“Over the last few months there have been 5 or 6 audits. Since we have invested quite significantly in terms of the cultural transformation in quality area, we actually got some of the places zero 483 which is again uncommon,” he concludes.