Lupin gets EIR from USFDA for Pithampur Unit 2 facility; stock zooms ~2%

12 Jul 2023 , 12:30 PM

Lupin announced that the USFDA has issued an establishment inspection report (EIR) with a voluntary action indicated (VAI) status for its Pithampur Unit-2 facility in Madhya Pradesh.

The EIR represents the completion of the inspection and paves the way for the US drug regulator to lift the facility’s warning letters.

VAI indicates that the facility is generally in compliance, with only minor violations that do not warrant action.

Lupin’s Indore Unit 2 facility received the warning letter in November 2017.

Lupin said that the successful completion of the inspection at the Pithampur facility will pave the way for the launch of generic Prolensa. It is an eye drop that lower inflammation in the eye after cataract surgery.

Lupin has an exclusive first-to-file license, and the product is expected to be available by the end of March 2024.

The USFDA inspected Pithampur Unit-3 in March of this year and issued ten observations.

At around 12.27 PM, Lupin was trading 1.77% higher at Rs 930.40, against the previous close of Rs 914.20 on NSE. The counter touched an intraday high and low of Rs 935 and Rs 915.05, respectively.

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