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Results For "Nagpur-facility"

20 News Found

Lupin receives USFDA nod for Famotidine injection
Drug Approval | May 15, 2026

Lupin receives USFDA nod for Famotidine injection

Famotidine Injection USP is a generic version of Pepcid injection to be manufactured at its Nagpur facility for the U.S. market


Lupin receives FDA tentative approval for Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets
Drug Approval | September 25, 2025

Lupin receives FDA tentative approval for Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets

Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets are indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg


Lupin receives tentative approval from USFDA for Oxcarbazepine ER Tablets
Drug Approval | June 09, 2025

Lupin receives tentative approval from USFDA for Oxcarbazepine ER Tablets

Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)


Lupin receives USFDA approval for Tolvaptan Tablets
Drug Approval | April 24, 2025

Lupin receives USFDA approval for Tolvaptan Tablets

Tolvaptan is indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease


Lupin receives tentative approval from USFDA for Abacavir, Dolutegravir and Lamivudine tablets for oral suspension
Drug Approval | December 09, 2024

Lupin receives tentative approval from USFDA for Abacavir, Dolutegravir and Lamivudine tablets for oral suspension

The fixed-dose combination of Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg tablets for oral suspension is a once-daily single-pill regimen


Lupin receives tentative approval from USFDA for Raltegravir Tablets
Drug Approval | November 09, 2024

Lupin receives tentative approval from USFDA for Raltegravir Tablets

This product will be manufactured at Lupin’s Nagpur facility in India


Lupin receives USFDA approval for Bumetanide Injection
Drug Approval | September 19, 2024

Lupin receives USFDA approval for Bumetanide Injection

Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.


Lupin receives approval from USFDA for Emtricitabine and Tenofovir Alafenamide Tablets
Drug Approval | August 01, 2024

Lupin receives approval from USFDA for Emtricitabine and Tenofovir Alafenamide Tablets

This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries


Lupin receives approval from US FDA for Ganirelix Acetate Injection
Drug Approval | November 20, 2023

Lupin receives approval from US FDA for Ganirelix Acetate Injection

The product will be manufactured at Lupin’s Nagpur facility in India


Lupin receives tentative approval from USFDA for Selexipag for injection
Drug Approval | November 04, 2023

Lupin receives tentative approval from USFDA for Selexipag for injection

This product will be manufactured at Lupin's Nagpur facility in India