The shares of Transnational Pharmaceutical Company surged as much as 4.3% on Wednesday’s trade after receiving tentative approval from USFDA for its generic version of a HIV Drug.
Share Price Movement
The shares of Lupin Ltd, with a market capitalization of ₹99,894 Crores, as of Wednesday afternoon were trading around ₹2,192 per share, 3.8% higher than the previous close of ₹ 2,111. The shares generated a return of 46% in 1 year, 155% in 3 years, and 203% in 5 years respectively.
What Happened
Lupin Ltd confirmed that it has received tentative approval from the U.S. Food and Drug Administration for its generic version of its combination HIV treatment.
The company has received tentative approval for its ANDA (Abbreviated New Drug Application) for Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Tablets, 800 mg/150 mg/200 mg/10 mg. Darunavir, cobicistat, emtricitabine, and tenofovir alafenamide is a combination of four drugs in a single tablet used to treat HIV-1 in adults and adolescents.
Lupin’s Product has been discovered to be a therapeutical equivalent of the reference listed drug Symtuza tablets of Janssen Products LP.
According to the IQVIA MAT data, Darunavir, Cobicistat, Emtricitabine, and Tenofovir Alafenamide Tablets had estimated annual sales of $1,374 Million in the US.
Lupin is the exclusive first-to-file for this product, and it will be manufactured at the Company’s Nagpur facility in India.
Financials
The company reported a 12.6% increase in Revenue from Operations from ₹5,039 Crores in Q2FY24 to ₹ 5,673 Crores. Its Net profits surged by 73% from ₹495 Crores to ₹859 Crores over the same period.
Recent Update
As per a press release dated February 1st ,2025, Lupin announced that the U.S. FDA has completed a Pre-Approval Inspection of Edaravone Oral Suspension, 105 mg/ 5 mL at its manufacturing facility in Somerset, New Jersey. The inspection concluded with zero 483 observations.
India Pharma Industry
The Indian Pharmaceutical industry is presently ranked third in pharmaceutical production by volume after evolving over time into a thriving industry growing at a CAGR of 9.43% since the past nine years. India has the highest number of pharmaceutical manufacturing facilities that comply with the USFDA and has 500 API producers that make for around 8% of the worldwide API market.
About Lupin Ltd
Headquartered in Mumbai, India, Lupin is a global pharmaceutical company with a footprint across the U.S., LATAM, APAC, EMEA and India, with products distributed in over 100 markets.
It has a diverse portfolio of over 1,200 products, that includes branded and generic formulations, biologic products and active pharmaceutical ingredients. It has a network of 15 manufacturing sites, 7 research centers, and a dedicated workforce of over 22,000 professionals.
Written By Adhvaitha Nayani
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