Lupin Ltd Share Price – NSE  / BSE

Pharmaceuticals, Mid Cap

The inspection was conducted between 2 March 2026 and 7 March 2026. Following the inspection, the US regulator issued Form 483, noting two observations at the facility.

The company said it will address the observations and respond to the US FDA within the stipulated timeframe. Lupin added that it remains committed to compliance with Current Good Manufacturing Practice (CGMP) standards across all its facilities.

Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

The pharmaceutical company reported a 37.46% surge in consolidated net profit to Rs 1,175.55 crore in Q3 FY26 as against Rs 855.16 crore posted in Q3 FY25. Total revenue from operations jumped 24.26% year-on-year to Rs 7,167.52 crore in the quarter ended 31 December 2025.

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Lupin has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its facility in Goa, India, with a satisfactory Voluntary Action Indicated (VAI) classification. The EIR was issued following an inspection of the facility from November 10 to November 21, 2025.

Nilesh Gupta, Managing Director, Lupin, stated, ?We are pleased to have received the EIR with a VAI classification from the US FDA for our Goa facility. This outcome reflects our continued focus on quality excellence and regulatory compliance, reinforcing our commitment to delivering safe and effective medicines to patients worldwide.?

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The EIR follows an inspection conducted at the site from 10 November to 21 November, 2025, confirming compliance with regulatory standards.

Nilesh Gupta, managing director (MD), Lupin, stated, ?We are pleased to have received the EIR with a VAI classification from the US FDA for our Goa facility. This outcome reflects our continued focus on quality excellence and regulatory compliance, reinforcing our commitment to delivering safe and effective medicines to patients worldwide.?

Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

The pharmaceutical company reported a 37.46% surge in consolidated net profit to Rs 1,175.55 crore in Q3 FY26 as against Rs 855.16 crore posted in Q3 FY25. Total revenue from operations jumped 24.26% year-on-year to Rs 7,167.52 crore in the quarter ended 31 December 2025.

Shares of Lupin shed 0.03% to currently trade at Rs 2,322.40 on the BSE.

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Lupin has received approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Brivaracetam Oral Solution 10 mg/mL. Brivaracetam is the bioequivalent to Briviact? Oral Solution, 10 mg/mL, of UCB, Inc. and is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.

Following the approval, the company initiated the launch of Brivaracetam Oral Solution in the United States.

Brivaracetam Oral Solution (RLD Briviact) had an estimated annual sale of USD 135 million in the U.S. (IQVIA MAT December 2025).

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