Approval for more than 60 ANDAs pending: DRL

Written By Unknown on Jumat, 05 Desember 2014 | 21.03

Over the last few months there have been 5 or 6 audits. Since DRL has invested quite significantly in terms of the cultural transformation in quality area, it got some of the places zero 483 which is uncommon, says CFO Saumen Chakraborty.

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.

Dr Reddys Labs stock price

On December 05, 2014, Dr Reddys Laboratories closed at Rs 3394.65, down Rs 77.6, or 2.23 percent. The 52-week high of the share was Rs 3662.00 and the 52-week low was Rs 2250.00.


The company's trailing 12-month (TTM) EPS was at Rs 125.08 per share as per the quarter ended September 2014. The stock's price-to-earnings (P/E) ratio was 27.14. The latest book value of the company is Rs 547.59 per share. At current value, the price-to-book value of the company is 6.20.


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