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.

Updated On: 06 Sep 2024 | 5:24 PM IST

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

Updated On: 12 Sep 2020 | 7:23 PM IST

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

Updated On: 19 Dec 2017 | 12:03 PM IST

Dr Reddy's launches anti-coagulant injection in US

Product to be available in packages of 10 single-dose vials

Updated On: 06 Jun 2017 | 5:14 PM IST

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

Updated On: 12 May 2017 | 9:00 PM IST