Indoco Remedies gets EIR from US FDA for Plant II & Plant III at Verna in Goa
Our Bureau, Mumbai
Friday, July 26, 2019, 15:30 Hrs [IST]
Indoco Remedies, a Rs.1,000 plus pharma major, announced that it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for their sterile facility (Plant II) and solid dosages facility (Plant III) at Verna, Goa. The inspection was held from 27th May, 2019 to 4th June, 2019, where the company had received 4 observations (483s).
Commenting on this positive development, Aditi Kare Panandikar, managing director – Indoco Remedies Ltd. said, “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 VAI 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.”
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.
Indoco Remedies Ltd, a fully integrated, research-oriented pharma company with presence in 55 countries. The company has 9 manufacturing facilities, 6 of which are for FDFs and 3 for APIs, supported by a state-of-the-art R&D Centre and a CRO facility. The facilities have been approved by USFDA, UK-MHRA, TGA-Australia, MCC-South Africa, etc.
|