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Tag: Lupin

Lupin launches fixed dose triple combo inhaler for COPD in India

Posted on October 7, 2026 By admin
Lupin launches fixed dose triple combo inhaler for COPD in India

Lupin | Photo Credit: Reuters 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…

Read More “Lupin launches fixed dose triple combo inhaler for COPD in India” »

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Lupin gets U.S FDA nod for Pitolisant tablets

Posted on August 17, 2026 By admin
Lupin gets U.S FDA nod for Pitolisant tablets

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….

Read More “Lupin gets U.S FDA nod for Pitolisant tablets” »

Business

Lupin takes 82.2% stake in Kaveri Therapeutics, licences 2 oncology assets for $1.6mn

Posted on July 21, 2026 By admin
Lupin takes 82.2% stake in Kaveri Therapeutics, licences 2 oncology assets for .6mn

Lupin, India’s No. 2 drugmaker,  spins-out two oncology programmes to Kaveri | Photo Credit: Reuters 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…

Read More “Lupin takes 82.2% stake in Kaveri Therapeutics, licences 2 oncology assets for $1.6mn” »

Business

Natco Pharma, Lupin alliance secures U.S. FDA nod for generic breast cancer drug

Posted on June 3, 2026 By admin
Natco Pharma, Lupin alliance secures U.S. FDA nod for generic breast cancer drug

The U.S. Food and Drug Administration has approved Natco Pharma’s abbreviated new drug application (ANDA) for cancer drug Eribulin Mesylate Injection. File | Photo Credit: Getty Images 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…

Read More “Natco Pharma, Lupin alliance secures U.S. FDA nod for generic breast cancer drug” »

Business

U.S. FDA nod for Lupin’s copy of Gilead Sciences’ HIV drug  

Posted on September 24, 2025 By admin
U.S. FDA nod for Lupin’s copy of Gilead Sciences’ HIV drug  

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…

Read More “U.S. FDA nod for Lupin’s copy of Gilead Sciences’ HIV drug  ” »

Business

Lupin gets U.S. FDA nod for two generic diabetes drugs 

Posted on July 24, 2025 By admin
Lupin gets U.S. FDA nod for two generic diabetes drugs 

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…

Read More “Lupin gets U.S. FDA nod for two generic diabetes drugs ” »

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