USFDA clears Indoco’s Goa Plant II and III

Indoco Remedies has announced 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 4th June, 2019, where the company had received four observations (483s).

Commenting on this positive development, Aditi Kare Panandikar, Managing Director – Indoco Remedies, 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 three ANDAs of injectable products filed through our partners."

The company has 33 ANDAs pending for approval, out of which, 17 are for ophthalmics, five are for injectables and 11 are for solid dosages from the site.

By EP News Bureau

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