Hyderabad, 8 September: Sending the remediation steps of Dr Reddy's Laboratories Limited for a toss, German Regulatory Authory has issued six major audit observations on the company's Duvvada formulations manufacturing plant, months after the US Food and Drug Administration(US FDA) slapped the facility with Form 483 with the highest number of 13 observations in a re-inspection sought by the company.This is the second instance where Dr Reddy's manufacturing facility has fallen short of quality compliances during a month's time. The German regulatory body had told the company last month that it was not going to renew the compliance certification of Unit 2 at Bachupally in Hyderabad, thus effectively halting the product exports to the EU member countries from that plant.There are no immediate financial implications from the latest regulatory action as Duvvada facility already stopped exporting any product to Europe.The development, however, raised serious doubts over the effectiveness ..
Aripiprazole is a therapeutic equivalent generic version of Ablify tablets in the US market
Company recognised for its corporate sustainability leadership, is sole pharma firm in index of emerging markets
ANDAs comprise of complex generic products across diverse dosage forms
Most important positive for the stock will be the resolution of the US inspector issues