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Lupin Shares Rise 2% on USFDA EIR for Dabhasa Facility

Tree observations about the finished product and API were made at the end of the inspection.

Shares of Lupin Ltd. surged by almost 2% to a day’s high of Rs 1838.15 on 15 July after the company secured the Establishment Inspection Report from the USFDA for its manufacturing unit located in Dabhasa, Gujarat.

The EIR was issued following an inspection of the Dabhasa facility from 8 April to 12 April 2024. The inspection concluded with no observations, and the facility received a “No Action Indicated” (NAI) classification.

The managing director of Lupin expressed satisfaction after receiving the EIR for Dabhasa from the USFDA. He emphasised the company’s ongoing dedication to upholding top-tier standards of quality and compliance across its operations and also reaffirmed its mission to provide high-quality and affordable healthcare solutions around the globe.

The facility is part of Lupin Manufacturing Solutions (LMS). LMS focuses on developing, manufacturing, and selling Active Pharmaceutical Ingredients and providing Contract Development and Manufacturing Operations.

The company’s sales in the US grew by 34% year-over-year in FY24, driven by improved regulatory performance and increased product sales regarding inhaling. The share of inhalation products in the US sales rose from 25% ($185 Million) in FY22 to 40% ($326 Million) in FY24, following the launch of gSpiriva, during the last year.

In India, the growth was subdued due to the discontinuance of in-licensed brands, with their contribution dropping from 15% in FY23 to around 11% in Q4 FY24.

At 3:30 PM, the shares of Lupin Ltd. closed 1.73% higher at Rs 1828.25 on BSE.

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