Drugmaker Lupin has launched Formoflo-G MDI, a fixed-dose triple combination metered-dose inhaler for chronic obstructive pulmonary disease (COPD) in India following approval from the Drug Controller General of India (DCGI).

Formoflo-G is a first-of-its-kind MDI that combines Glycopyrronium Bromide, Formoterol Fumarate and Fluticasone Propionate for the long-term management and treatment of moderate to severe COPD. It is available as a twice-daily, single-strength fixed dose, Lupin said on Tuesday.

The product is an important addition to Lupin’s respiratory portfolio, bringing together three established therapies in a single inhaler, said Rajeev Sibal, President – India Region Formulations.

Managing Director Nilesh Gupta said “as respiratory diseases continue to impact millions across India, access to effective therapies remains critical. Formoflo-G MDI reflects our commitment to addressing unmet patient needs through differentiated, high-quality therapies.”

Drugmaker Lupin on Monday said it has received the final approval from the U.S. Food and Drug Administration (U.S. FDA) for its abbreviated new drug application for Pitolisant Tablets, 4.45 mg and 17.8 mg.

The U.S. FDA has approved the company’s generic as bioequivalent to Harmony Biosciences’ Wakix for the indications in the approved labeling. A prescription medicine, Wakix is used to treat excessive daytime sleepiness (EDS) or cataplexy in people 6 years of age and older with narcolepsy.

Global pharma major Lupin has spun-out two oncology programmes to Kaveri Therapeutics Inc for $1..6 million, taking its stake in the U.S. clinical-stage oncology company to 82.2%.

Its wholly-owned US subsidiary Lupin Inc (LI), which has entered into a licensing arrangement with Kaveri to grant exclusive perpetual license for two of its oncology programmes — LNP7457 (PRMT5) and LNP8701 (SOS1) — will provide seed funding to Kaveri. LI has received 332,000 common shares (82.2% equity stake) in Kaveri, in exchange of license, the company said in its regulatory filing.

Kaveri will advance the programme through global clinical trials. It will also raise additional capital to fund the clinical development efforts. The clinical-stage oncology company was incorporated this May to focus on the early-stage clinical development of therapies for solid tumors, including lung, pancreatic, ovarian, and CNS-related cancers.

Both the oncology programmes demonstrated encouraging clinical progress and reported positive data at the American Society of Clinical Oncology (ASCO) meeting in 2025 and 2026, respectively, Lupin said, announcing signing of a licensing agreement to grant an exclusive perpetual licence to Kaveri.

“Proud to have pioneered these oncology assets and look forward to advancing them through Kaveri Therapeutics,” Lupin CEO Vinita Gupta said.

The U.S. Food and Drug Administration (U.S FDA) has approved Natco Pharma’s abbreviated new drug application (ANDA) for cancer drug Eribulin Mesylate Injection, 1 mg/2ml (0.5 mg/ml) single-dose vials, the generic drugmaker and its alliance partner Lupin said on Wednesday (June 3, 2026).

The approved product is the bioequivalent to the reference listed drug (RLD) Halaven injection of Eisai Inc. The RLD (Halaven) had an estimated annual sales of $43.7 million in the U.S., the two companies said citing IQVIA MAT April 2026 numbers. Eribulin Mesylate injection is indicated for the treatment of adults with metastatic breast cancer.

Generic drugmaker Lupin has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application for Bictegravir, Emtricitabine and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg.

The tablets are bioequivalent to Gilead Sciences Biktarvy Tablets, 50 mg/200 mg/25 mg and indicated for treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg. Lupin said it would be manufacturing the product at its Nagpur facility.

Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets (RLD Biktarvy) had estimated annual sales of $16,237 million in the U.S., the company said citing IQVIA MAT July 2025 numbers.

Generic drugmaker Lupin has received U.S. Food and Drug Administration approval for its abbreviated new drug applications for Liraglutide Injection single-patient-use prefilled pens and Glucagon for injection vials.

Both the products will be manufactured at the company’s injectable facility in Nagpur, Lupin said.

Liraglutide injection 18 mg/3 mL (6 mg/mL) single-patient-use prefilled pen is bioequivalent to Novo Nordisk’s Victoza injection and had an estimated annual sale of $458 million in the U.S, the company said citing IQVIA MAT May numbers. The drug is indicated to improve glycaemic control in adults and children, aged above 10 years, with type 2 diabetes mellitus.

Glucagon for Injection USP, 1 mg/vial, is bioequivalent to Eli Lilly and Company’s Glucagon for Injection, 1 mg/vial. It is indicated for treatment of severe hypoglycaemia in paediatric and adult patients with diabetes mellitus and as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients. It had an estimated annual sale of $124 million in the U.S.

Chief Scientific Officer Shahin Fesharaki said the two products are a meaningful enhancement to the company’s portfolio.