USFDA green signal to Indoco’s Goa Plant II & III
Mumbai: Indoco Remedies announced today that it has received the Establishment Inspection Report (EIR)from the US Food and Drug Administration (USFDA)for their sterile facility (Plant II) and solid dosages facility (Plant III) at Verna, Goa. The inspection was held from 27th May, 2019 to 4thJune, 2019, where the Company had received 4 observations (483s). The Company has 33 ANDAs pending for approval, out of which, 17 are for ophthalmics, 5 are for injectables and 11 are for solid dosages from the site.
“We are happy to receive the EIR in less than two months from the date of inspection. This is encouraging, as the site has been endorsed with the VAl status twice this year, by the US Regulators. The recent inspection was a Pre-Approval Inspection for 3 ANDAs of injectable products filed through our partners” Ms. Aditi Kare Panandikar, Managing Director -Indoco Remedies Ltd. said.