Lupin surges to 52-week high on receiving US FDA clearance for Nagpur unit

The US FDA classified Lupin’s Nagpur unit as Voluntary Action Indicated.

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Shares of Lupin surged around 4 percent and scaled a 52-week high of Rs 1,184.70 on September 29 after the company received an Establishment Inspection Report (EIR) for its Nagpur unit-I manufacturing facility from the US Food and Drugs Administration.

The EIR, which indicates the closure of an inspection, classified Lupin’s Nagpur unit as Voluntary Action Indicated (VAI). The FDA classifies any site as VAI when it finds lags during its inspection, the severity of which is not enough to prompt an official action.

The USFDA had issued Form-483 with two observations for Lupin’s Nagpur oral solid dosage facility in July earlier this year.

Lupin has struggled with clearance for quite some time and the VAI status brought cheer to the investors as it is a step in the right direction.

The USFDA classifies a manufacturing unit as a VAI when it finds lapses during its inspection but doesn’t deem it significant enough to prompt an official action. With the VAI status, companies can go ahead and receive approvals for drugs from the site and also proceed with commercialisation of previously approved drugs. It is the second-best classification that a manufacturing facility of a pharma company can get from the US FDA.

Lupin had said in its Q1 earnings meet that it cleared three sites that were under the US FDA’s warning letter and is focused on remediation efforts for Tarapur and Mandideep sites. Both sites were caught under regulatory challenges since November 2022.

At 3.09 pm, shares of Lupin were trading 3.35 percent higher at Rs 1,171 on the NSE.