Lupin gets EIR for Pithampur Unit-2, paves way for resolving warning letter

economictimes.indiatimes.com:

Lupin on Tuesday said it has received establishment inspection report (EIR) from the US FDA with a voluntary action indicated (VAI) status for its Pithampur Unit-2 facility in Madhya Pradesh. The EIR represents the closure of the inspection, and also paves the way for possible lifting of warning letters on the facility imposed by the US drug regulator. VAI means the facility is generally in compliance, with only minor violations that do not meet the threshold for action.

Lupin’s Indore Unit 2 plant has been under warning letter since November 2017. The successful closure of inspection at Pithampur Unit-2, will clear the hurdle for the launch of generic Prolensa — an eye drop that lowers eye inflammation after cataract surgery, which was filed from the facility. Lupin has an exclusive first to file, the product is expected to be launched towards the end of March 2024.

«We are pleased to have received the EIR from the US FDA with a satisfactory VAI status for our Pithampur Unit-2 facility,» said Nilesh Gupta, MD of Lupin. «This is a significant milestone as we build back our reputation of being best-in-class in quality and compliance,» Gupta added. Gupta said the company can look forward to new products approvals and launches, especially ophthalmic products from this facility.

The Pithampur Unit-3 was inspected by USFDA in March this year, and was issued 10 observations Lupin has gradually downsized its operations at Unit-2 following the warning letter in 2017. The warning letter has restricted new approvals from the facility. Lupin has been on path to resolve regulatory compliance issues that plagued some of its plants.