 "Lupin")
Mumbai-based global pharmaceutical company Lupin Limited (Lupin) on Friday announced that it has received tentative approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application for apalutamide tablets, 60 mg, to market a generic equivalent of erleada tablets, 60 mg of Janssen Biotech, Inc.
This product will be manufactured at Lupin’s Pithampur facility in India, said the company. Apalutamide tablets, 60 mg, (RLD Erleada) had estimated annual sales of $1,185.5 million in the US.
It has also received tentative approval from the USFDA for its abbreviated new drug application for calcium, magnesium, potassium, and sodium oxybates oral solution, 0.5 g/mL.
According to the company, tentative approval is granted to market a generic equivalent of xywav oral solution, 0.5 g/mL of Jazz Pharmaceuticals Ireland Limited.
This product will be manufactured at Lupin’s Somerset facility in the US. The company stated that Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch.
The net product sales for calcium, magnesium, potassium, and sodium oxybates oral solution were USD 958.4 million for the year ending December 2022 and USD 604.3 million for the first six months of 2023.
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The company also received an Establishment Inspection Report (EIR) from the USFDA for its Nagpur Unit-I manufacturing facility. The EIR was issued following an inspection of the facility conducted in July 2023.
All you need to know about Lupin
Lupin develops and commercialises a wide range of branded and generic formulations, biotechnology products, and Active Pharmaceutical Ingredients (APIs) in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas.
It is also the third-largest pharmaceutical company in the US by prescription. The company invested 7.9 per cent of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognised as a ‘great place to work’ in the biotechnology & pharmaceuticals sector.
