Lupin launches Formoflo-G triple-combination COPD inhaler in India

Lupin Limited said on 6 October 2026 that it had launched Formoflo-G in India, a metered-dose inhaler that combines glycopyrronium bromide, formoterol fumarate and fluticasone propionate in a single fixed dose, for the long-term management and treatment of moderate to severe chronic obstructive pulmonary disease (COPD). The company said in a release datelined Mumbai that the product had been approved by the Drug Controller General of India (DCGI).

Lupin describes Formoflo-G as the world’s first fixed-dose triple combination metered-dose inhaler for COPD in India, and as a first-of-its-kind inhaler. Those are the company’s claims. The release does not cite a regulatory document, patent or study to support them, and The Healthcare Daily has not independently verified them. According to the release, the inhaler is taken twice daily in a single strength; the strengths of the three components are not given.

The release does not disclose the price, the manufacturing site, the date of the DCGI approval, sales expectations or any clinical study supporting the product.

Where the launch fits in Lupin’s India business

Lupin said it ranks second in the respiratory therapy segment in India, citing IQVIA data for the moving annual total to March 2026. The company also said more than 55 million people in India live with COPD, which it described as a leading cause of death and disability; the release gives no source for that figure.

Nilesh Gupta, the managing director, said that because respiratory diseases affect millions of people in India, access to effective therapies is essential, and that the launch was part of the company’s effort to meet unmet patient needs with differentiated, high-quality therapies. Rajeev Sibal, president of India region formulations, said the inhaler adds to Lupin’s respiratory portfolio by combining three established therapies in one device, and described it as a treatment option for suitable COPD patients.

Lupin said it has 15 manufacturing facilities, six research centres and more than 26,000 employees, with products distributed in more than 100 markets.

A second product announcement in the same week

Two days later, in a release dated 8 October 2026, Lupin said the US Food and Drug Administration had approved its abbreviated new drug application for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL, in a single-dose prefilled syringe. The company said the product is bioequivalent to the reference listed drug from International Medication Systems, Limited, and cited IQVIA MAT data putting estimated annual US sales at USD 52.3 million for the period ending August 2026. That release did not name the manufacturing site or give a launch date.

Together the two announcements show Lupin adding to both its domestic branded portfolio and its US generics list in the same week, though neither release gives revenue guidance for the new products.

Our reading

Analysis by The Healthcare Daily.

• A single inhaler carrying three established molecules gives Lupin a new product with which to defend its stated second place in Indian respiratory sales. Uptake will depend on price and prescriber behaviour, neither of which the company has disclosed.
• For competitors in India’s respiratory market, the first-of-its-kind label is a positioning statement rather than a confirmed exclusivity: the release cites no patent, data protection or regulatory exclusivity.
• Hospital and pharmacy buyers will need pack prices before they can compare Formoflo-G with regimens that use the same molecules in separate inhalers.