Dr Reddy's Us
Dr Reddy's gets USFDA's inspection report for Srikakulam-based API plant
Dr Reddy's Laboratories on Friday said it has received the establishment inspection report (EIR) from the US health regulator for its active pharmaceutical ingredient manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh. The US Food and Drug Administration (USFDA) has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is close, the Hyderabad-based drug maker said in a statement. As per USFDA, VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. On June 7 this year, Dr Reddy's had stated that the US health regulator has issued Form 483 with four observations after inspecting its Srikakulam-based facility. Shares of the company on Friday ended 0.42 per cent down at Rs 6,669.75 apiece on the BSE.
 "Dr Reddy's gets USFDA's inspection report for Srikakulam-based API plant")
Slew of new drug launches, patent victory to drive Dr Reddy's US business
Ongoing pace of product launches in the US should lead to stronger growth after a good Q1, say analysts
 "Slew of new drug launches, patent victory to drive Dr Reddy's US business")
Dr Reddy's settles 6-yr-old drug packaging case with US govt for $5 mn
Dr Reddy's said products with the packaging at issue have not been distributed since June 2012
 "Dr Reddy's settles 6-yr-old drug packaging case with US govt for $5 mn")
Dr Reddy's launches anti-coagulant injection in US
Product to be available in packages of 10 single-dose vials
 "Dr Reddy's launches anti-coagulant injection in US")
Dr Reddy's aims to launch 10 products in US in 2017 after 'bad year'
Dr Reddy's says US drug approvals are hard to get after
 "Dr Reddy's aims to launch 10 products in US in 2017 after 'bad year'")
