Lupin Pithampur Manufacturing Facility Gets EIR From USFDA

Lupin Limited, headquartered in Mumbai, India, is a global pharmaceutical leader with a presence in over 100 markets. Specialising in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients, Lupin is trusted by healthcare professionals and consumers worldwide. 

Clearance from the USFDA 

Lupin has announced that its Pithampur Unit-1 manufacturing facility has been granted a Voluntary Action Indicated (VAI) classification by the United States Food and Drug Administration (US FDA). The FDA issued an Establishment Inspection Report (EIR) following a thorough inspection of the site conducted between September 16th and 27th, 2024.

Managing Director Statement

Expressing his satisfaction, Nilesh Gupta, Managing Director of Lupin, stated, “We are delighted to receive the EIR from the US FDA for our Pithampur Unit-1 facility with a positive VAI classification. This underscores our unwavering commitment to maintaining the highest standards of quality and regulatory compliance.”

The successful resolution of these observations and the recent accolades mark yet another milestone in Lupin’s journey towards global excellence and market leadership.

Lupin Q2 FY25 Results

The recognition comes as Lupin Limited reports an impressive set of financial results for the second quarter of FY25. The company’s consolidated net profit soared by a staggering 74% year-on-year to ₹853 crore, compared to ₹489.7 crore in the corresponding quarter of the previous fiscal year. Revenue from operations witnessed a robust growth of 12.6%, reaching ₹5,672.7 crore against ₹5,038.6 crore in Q2 FY24.

EBITDA also experienced a notable surge, increasing by 42% to ₹1,308 crore. Consequently, EBITDA margins expanded significantly to 23.1% from 18.3% in the same period last year. This remarkable performance was driven by robust sales across key markets, including North America and India, alongside a strategic focus on complex generics.

Share Price and Performance 

At 9:53 AM on January 9, 2025, Lupin Ltd shares were trading at ₹2,257.10 on the NSE.

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