Lupin Ltd, a global pharmaceutical company, has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules. The approved capsules are available in strengths of 2.5 mg to 25 mg and are used to treat adult patients with Multiple Myeloma, a type of blood cancer, in combination with dexamethasone. The capsules will be manufactured at Lupin’s Pithampur facility in India.
This approval is significant, as the estimated annual sales of Lenalidomide Capsules in the United States are around $7,511 million. Lupin is a leading player in the pharmaceutical industry, 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.
With a dedicated workforce of over 24,000 personnel, Lupin has a strong position in both India and the US, excelling in multiple therapy areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. The company has 15 state-of-the-art manufacturing sites and seven research centers across the world, demonstrating its commitment to innovation and quality.
The approval of Lenalidomide Capsules is a testament to Lupin’s capabilities in developing and manufacturing complex generic products. The company’s strong research and development capabilities, combined with its global manufacturing footprint, enable it to bring high-quality products to patients worldwide. With this approval, Lupin is well-positioned to capitalize on the growing demand for generic pharmaceuticals in the US market.
Overall, the approval of Lenalidomide Capsules is a significant milestone for Lupin, demonstrating its ability to develop and manufacture complex generic products that meet the stringent regulatory standards of the US FDA. The company’s commitment to innovation, quality, and patient care is evident in its continued investments in research and development, manufacturing, and global expansion.