On July 12, 2023, Pharma major Lupin’s share price moved to a 52-week high of Rs 934.90, gaining 2% in early morning trade after the business acknowledged an Establishment Inspection Report (EIR) from the USFDA.
At 9:23 am, Lupin was trading at Rs 921.35, up Rs 8.45, or 0.93% on the BSE.

Lupin has acknowledged the Establishment Inspection Report (EIR) from the United States Food and Drug Administration for its Pithampur Unit-2 industrial facility that manufactures oral solids and ophthalmic dosage procedures.

The EIR was delivered post the facility’s last inspection conducted from March 21 to March 29, 2023. The USFDA has resolute that the inspection classification of the unit is Voluntary Action Indicated (VAI).

The Managing Director of Lupin said they are pleased to receive the EIR from the USFDA with a satisfactory VAI status for our Pithampur Unit-2 unit. This is a significant breakthrough in building a reputation for quality and compliance again. The firm looks forward to new product sanctions and launches ophthalmic products from this facility.

On July 4, 2023, the company received tentative approval from the USFDA for its condensed new drug application (ANDA), Dolutegravir tablets for oral suspension, 5 mg. The sanction is to market a generic equivalent of Tivicay PD Tablets for oral suspension, 5 mg of ViiV Healthcare company. This product will be manufactured at Lupin’s Nagpur unit in India.