USFDA concludes inspection at Lupin’s Nagpur facility with no observations

The inspection was carried out between June 10 and June 13, 2024. The inspection ended with zero Form 483 observations, indicating compliance with regulatory standards, the pharma company informed the stock exchanges in a filing.

Commenting on the development, Nilesh Gupta, the managing director of Lupin, said, “We are pleased to have a successful outcome of the USFDA inspection at our Nagpur injectable facility with zero observations. This reflects our dedication to uphold the highest quality and compliance standards across our facilities.”

In a separate filing on June 7, Lupin announced its decision to initiate a business transfer agreement with its wholly-owned subsidiary, Lupin Life Sciences Limited. The pharmaceutical company intends to segregate its trade generics business in India as a going concern through a slump sale basis. Lupin had previously communicated its intent to enter into this agreement in a letter to the exchanges dated March 22, 2024. As per the agreement’s terms, the carve-out process is slated to commence from July 1.

In the quarter ended March 2024, Liupin recorded a consolidated net profit of ₹359.4 crore, marking a 52% year-on-year (YoY) increase compared to ₹236 crore in the same quarter a year ago.

Total revenue from operations for the January-March quarter of FY24 stood at ₹4,961 crore, reflecting a 12% YoY growth from ₹4,430 crore in the corresponding period of the previous fiscal year. Lupin’s EBITDA also saw a 66.8% rise in Q4FY24 reaching ₹1,026.1 crore, compared to ₹615 crore in Q4FY23. The company’s EBITDA margin stood at 14.2%.

Shares of Lupin Ltd closed 0.12% lower at ₹1603 apiece on the NSE.