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Lupin gets USFDA warning letter
Sep 29 2022 11:55AM
Lupin fell 1.44% to Rs 660.85 after the company said its Tarapur facility in Maharashtra has received US drug regulator's warning letter.  
  
This action follows the inspection of the unit by the US Food and Drug Administration (USFDA) from 22 March 2022 to 4 April 2022. 
Lupin said it believes that the USFDA warning letter will not impact the supplies or the existing revenues from operations of this facility. 

The pharma major said it will address the concerns raised by the U.S. FDA and will work with the U.S. drug regulator to resolve these issues at the earliest. 

In an exchange filing the company said, “We uphold quality and compliance issues with utmost importance and remain committed to be compliant with CGMP quality standards across all our facilities.” 

Lupin is an innovation-led transnational pharmaceutical company. The company 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 drug maker reported a net loss of Rs 89.1 crore in Q1 FY23 as against a net profit of Rs 542.5 crore in Q1 FY22. Total revenue from operations declined 12.3% YoY to Rs 3,743.8 crore during the quarter.