Global pharma major Lupin Limited (Lupin) announced that it has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for empagliflozin, linagliptin and metformin hydrochloride extended-release (ER) tablets, 5 mg/2.5 mg/1,000 mg, 10 mg/5 mg/1,000 mg, 12.5 mg/2.5 mg/1,000 mg, and 25 mg/5 mg/1,000 mg, to market a generic equivalent of Trijardy XR tablets, 5 mg/2.5 mg/1,000 mg, 10 mg/5 mg/1,000 mg, 12.5 mg/2.5 mg/1,000 mg, and 25 mg/5 mg/1,000 mg, of Boehringer Ingelheim Pharmaceuticals, Inc. This product will be manufactured at Lupin’s Pithampur facility in India.
Lupin Pharm`s Generic Empagliflozin Receives Tentative Approval in US
Lupin acquires two diabetes brands from Boehringer Ingelheim
Sun's Generic Empagliflozin, Linagliptin Receives Approval in the U.S.
Sun's Generic Linagliptin, Metformin HCL Receives Receives Approval in the U.S.
Zydis' Generic Linagliptin, nMetformin Hydrochloride Receives Approval in the U.S.
Zydis' Generic Linagliptin Receives Approval in the U.S.
Torrent Pharmaceuticals (Torrent) has entered into a strategic alliance with Boehringer Ingelheim India Private Limited (BI India) to co-market Cospiaq (Empagliflozin), Cospiaq Met (Empagliflozin+ Metformin) and Xilingio (Empagliflozin+ Linagliptin) in India.
Phase III trial demonstrated Jardiance is the first SGLT2 inhibitor to show statistically significant reduction in blood sugar levels in children and adolescents with type 2 diabetes
India’s drug pricing authority has fixed prices of two key anti diabetes drugs-Sitagliptin-Metformin combination and Linagliptin-metformin combination. The two anti-diabetic drugs are among the 45 drug formulations whose retail prices have been fixed by the National Pharmaceutical Pricing Authority (NPPA).