Lupin has received approval from the US Food and Drug Administration (US FDA) for Phytonadione Injectable Emulsion USP, 1 MG/0.5 ML Single-dose Prefilled Syringe.

Regulatory approval details

The US FDA clearance covers Phytonadione Injectable Emulsion in a pre-filled syringe format at a concentration of 1 MG/0.5 ML. The approval confirms the product is bioequivalent to the reference listed drug (RLD), Phytonadione Injectable Emulsion, 1 mg/0.5 mL, of International Medication Systems, Limited. It is indicated for the treatment and prophylaxis of hypoprothrombinemia (low blood clotting) and vitamin K-deficiency.

The following table summarises the key details of the approved product.

This approval adds an injectable emulsion product to Lupin's US portfolio, reflecting the company's continued engagement with the US regulatory process for pharmaceutical products.

Market opportunity

Phytonadione Injectable Emulsion had estimated annual sales of $52.3 million in the U.S., according to IQVIA data for the moving annual total (MAT) ending August 2026. This figure highlights the commercial potential of the newly approved generic entry into the US market.

Lupin Limited launched Formoflo-G MDI, the world's first fixed-dose triple combination metered-dose inhaler for chronic obstructive pulmonary disease (COPD) management in India. The product received approval from the Drug Controller General of India (DCGI), offering a new treatment option for moderate to severe cases.

The launch addresses a significant public health challenge, as more than 55 million people in India live with COPD. It remains a leading cause of death and disability in the country. Formoflo-G combines three established therapies: Glycopyrronium Bromide, Formoterol Fumarate, and Fluticasone Propionate. This single-strength, twice-daily formulation simplifies long-term management for patients.

Strategic positioning in respiratory care

Lupin ranks second in the Indian respiratory therapy segment, according to IQVIA data for the moving annual total (MAT) ending March 2026. The introduction of Formoflo-G reinforces this leadership position by expanding the company's portfolio with a differentiated therapy.

Nilesh Gupta, Managing Director of Lupin, stated that the launch reflects the company's commitment to addressing unmet patient needs through high-quality therapies. He emphasized the goal of improving outcomes for respiratory disease patients by combining innovation with accessibility.

Rajeev Sibal, President of India Region Formulations at Lupin, noted that the product strengthens the company's respiratory portfolio. He highlighted that it provides healthcare professionals with an important treatment option for appropriate COPD patients.

Product specifications and market context

The new inhaler is designed for the long-term management and treatment of moderate to severe COPD. By integrating three active ingredients into one device, it aims to enhance patient compliance and therapeutic efficacy.

Lupin operates as a global pharmaceutical leader headquartered in Mumbai, with products distributed in over 100 markets. The company maintains strong leadership in the US and India across core therapeutic areas, including cardiovascular, respiratory, diabetes, gastrointestinal, and women's health. Its infrastructure includes 15 manufacturing facilities and six research centers supporting a workforce of over 26,000 professionals.