Lupin Ltd, a global pharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules. The capsules, which will be manufactured at Lupin’s Pithampur facility in India, are indicated for the treatment of adult patients with multiple myeloma, transfusion-dependent anemia, and other related conditions. The FDA approval is a significant milestone for Lupin, as Lenalidomide Capsules had estimated annual sales of $7,511 million in the United States.
Lupin Ltd is a Mumbai-based company with a strong presence in over 100 markets worldwide. The company specializes in a range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin has a significant presence in India and the US, with a focus on multiple therapy areas such as respiratory, cardiovascular, and women’s health.
The company has a robust infrastructure, with 15 state-of-the-art manufacturing sites and seven research centers globally. Lupin also has a dedicated workforce of over 24,000 professionals and several subsidiaries, including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. This is not the first FDA approval for Lupin, as the company received approval for its generic ‘Minzoya’ tablets last year. The Minzoya tablets are used to prevent pregnancy and are a generic equivalent of Balcoltra tablets.
The FDA approval for Lenalidomide Capsules is a testament to Lupin’s commitment to providing high-quality and affordable pharmaceutical products to patients worldwide. The company’s Pithampur facility in India, where the capsules will be manufactured, is a key part of Lupin’s global manufacturing network. With this approval, Lupin is well-positioned to expand its presence in the US market and provide patients with access to affordable and effective treatments for multiple myeloma and other related conditions. Overall, the FDA approval is a significant achievement for Lupin and reflects the company’s ongoing efforts to develop and market high-quality pharmaceutical products.