Lupin Limited , a prominent player in the pharmaceutical industry, has disclosed the outcome of a recent U.S. Food and Drug Administration (FDA) inspection at its Pune Biotech facility. The product-specific Pre-Approval Inspection, conducted from September 8 to September 19, concluded with four observations.

Inspection Details

The U.S. FDA carried out a thorough examination of Lupin's Pune Biotech facility as part of a product-specific Pre-Approval Inspection. This process is crucial for pharmaceutical companies seeking approval for new products or changes to existing ones.

While the specific nature of the observations was not disclosed, Lupin confirmed that the inspection resulted in four observations from the FDA. These observations typically highlight areas where the agency believes improvements or clarifications are needed to ensure compliance with Current Good Manufacturing Practice (CGMP) regulations.

Lupin's Response

In response to the FDA's findings, Lupin has stated its commitment to addressing these observations promptly. The company plans to provide a comprehensive response to the U.S. FDA within the stipulated timeframe, demonstrating its dedication to resolving any concerns raised during the inspection.

Lupin reaffirmed its unwavering commitment to maintaining CGMP quality standards across all its facilities. This commitment underscores the company's focus on ensuring the highest levels of quality and safety in its pharmaceutical manufacturing processes.

Recent Developments

In a separate development, Lupin received U.S. FDA approval for its generic Lenalidomide Capsules (2.5 mg to 25 mg) on September 18. This approval marks a significant milestone for the company in expanding its product portfolio in the U.S. market.

Company Overview

Lupin, headquartered in Mumbai, is a global pharmaceutical company with a presence in over 100 markets. The company specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.

Market Performance

Following the news, Lupin's shares closed 0.51% lower at Rs 2,057.00 on the stock market. The company's stock has experienced a decline of 5.37% over the last 12 months and 12.74% year-to-date.

The outcome of this inspection and Lupin's response will be closely watched by industry observers and stakeholders, as it could have implications for the company's product approvals and overall standing with the U.S. FDA.

Lupin Limited , a global pharmaceutical leader, has achieved a significant milestone in its product portfolio expansion. The company announced on September 17, 2025, that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules in six strengths: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg.

Key Highlights

• Lupin's Lenalidomide Capsules are bioequivalent to Bristol-Myers Squibb's Revlimid®, a widely used cancer treatment.
• The capsules will be manufactured at Lupin's Pithampur facility in India.
• Lenalidomide is indicated for treating multiple myeloma and certain types of myelodysplastic syndromes.
• The reference drug Revlimid® had estimated annual U.S. sales of USD 7,511.00 million, according to IQVIA data through July 2025.

Therapeutic Applications

Lenalidomide Capsules are approved for use in adult patients for:

1. Multiple myeloma (MM) treatment, in combination with dexamethasone
2. MM maintenance following autologous hematopoietic stem cell transplantation
3. Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality

Market Impact

The approval of Lupin's generic version of Lenalidomide could potentially increase access to this critical medication for cancer patients. With the reference drug Revlimid® having substantial annual sales in the U.S., Lupin's entry into this market segment could lead to increased competition and potentially more affordable treatment options for patients.

Company's Commitment to Quality

Lupin's ability to secure FDA approval for this complex generic drug underscores its commitment to quality and regulatory compliance. The company's Pithampur facility, where the Lenalidomide Capsules will be manufactured, has demonstrated its capability to produce high-quality pharmaceutical products that meet stringent U.S. FDA standards.

Recent Regulatory Inspection

In a separate but related development, Lupin disclosed on September 16, 2025, that the U.S. FDA conducted an inspection of its Nagpur Injectable facility from September 8 to September 16, 2025. The inspection concluded with six observations, which the company has committed to address within the stipulated timeframe. Lupin reaffirmed its commitment to maintaining CGMP quality standards across all its facilities.

About Lupin Limited

Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India. With a presence in over 100 markets, Lupin specializes in a wide range of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company has established a strong position in India and the U.S. across multiple therapeutic areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health.

The approval of Lenalidomide Capsules represents another step forward in Lupin's mission to improve patient health outcomes globally. As the company continues to expand its product portfolio and navigate regulatory challenges, it remains focused on delivering high-quality, affordable medications to patients worldwide.