Lupin's USA facility gets 6 USFDA observations

Lupin said that US Food and Drug Administration (USFDA) issued form 483 with six observations after the inspection conducted at its Somerset, New Jersey manufacturing facility.

The Pre-approval inspection was conducted from 7 May 2024 to 17 May 2024, and closed with an issuance of a Form-483 with six observations.

It will respond to the U.S. FDA within the stipulated timeframe.

Mumbai-based Lupin is an innovation-led transnational pharmaceutical company.

It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The companys consolidated net profit tumbled 41.38% to Rs 359.43 crore on 3.64% decline in revenue from operations to Rs 4895.11 crore in Q4 FY24 over Q4 FY23.

The scrip rose 0.45% to end at Rs 1,659.95 on Saturday, 20 May 2024.